医疗器械监管框架2014年七月

M ANUAL ON B ORDERLINE AND C LASSIFICATION IN THE C OMMUNITY R EGULATORY F RAMEWORK FOR M EDICAL D EVICES

Version 1.16 (07-2014)

P LEASE NOTE:T HE VIEWS EXPRESSED IN THIS MANUAL ARE NOT LEGALLY

BINDING; ONLY THE E UROPEAN C OURT OF J USTICE (“C OURT”) CAN GIVE AN AUTHORITATIVE INTERPRETATION OF C OMMUNITY LAW.

M OREOVER, THIS MANUAL SHALL ONLY SERVE A S “TOOL” FOR THE CASE-

BY-CASE APPLICATION OF COMMUNITY-LEGISLATION BY THE M EMBER-S TATES.I T IS FOR THE NATIONAL COMPETENT AUTHORITIES AND

NATIONAL COURTS TO ASSESS ON A CASE-BY-CASE BASIS.

T HE CONTENT OF THIS MANUAL AND ALL UPDATES ARE PRESENTED TO THE

WORKING GROUP ON BORDERLINE AND CLASSIFICATION FOR CONSULTATION.T HIS GROUP IS CHAIRED BY THE C OMMISSION AND IS COMPOSED OF REPRESENTATIVES OF ALL M EMBER S TATES OF EU,EFTA

AND OTHER STAKEHOLDERS

INTRODUCTION (6)

1.MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE –

MEDICAL INTENDED PURPOSE (8)

Introduction (8)

1.1.Light box indicated to treat seasonal affective disorder (S.A.D) (8)

1.2.AB0 and Rhesus (D) blood grouping intended for diet purposes (9)

1.3.Pharmacy compounders (10)

1.4.Dental disclosing products (10)

1.5.Mixer (11)

1.6.Non-corrective contact lenses with a medical purpose (11)

1.7.Biofunctional clothes (12)

1.8.System for the determination of bacterial contamination in blood

products (13)

1.9.Independent in-vivo dosimeters (14)

1.10.Gallipots (14)

1.11.Shoe covers (14)

1.12.Urine Diverter / Funnel Element for Mid-Stream Urine Collection (15)

1.13.Air purifiers / Air decontamination units / Mobile air decontamination

units (16)

1.14.Wigs and head scarves (17)

1.15.Blood irradiation indicators (18)

1.16.Odour neutralizers (18)

1.17.Bedwetting alarm (19)

- Background (19)

2.BORDERLINE IN VITRO DIAGNOSTIC MEDICAL DEVICE (19)

Introduction (19)

2.1.Sample receptacles and sampling devices which are intended to be

used for the collection by the lay user of samples, which are

subsequently examined by third persons (20)

2.2.CE labelled microscope slides (21)

2.3.Single or multiple channel pipettes (21)

3.BORDERLINE ACTIVE IMPLANTABLE MEDICAL DEVICE –

MEDICAL DEVICE (22)

3.1.Bone anchored hearing aids (22)

4.BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT (23)

Introduction (23)

4.1.Product for testing patient reflex cough (24)

4.2.Elastoviscous fluids (25)

4.3.In-Vitro Fertilisation (IVF) and Assisted Reproductive Technologies

(ART) products (26)

4.4.Peritoneal dialysis solutions (27)

4.5.Agents for transport, nutrition and storage of organs intended for

transplantation (28)

4.6.Zinc oxide containing creams (29)

4.7.Eye drops intended for related to the alleviation of ‘soreness’ ,

‘discomfort’ or ‘irritation’ caused by environmental factors (such as

dust, heat, smoke etc) (30)

4.8.Product for use in acute sore throat (31)

4.9.Plaster with capsaicin (32)

4.10.Gold implants for treatment of osteoarthrosis (32)

4.11.Substances for chemical peeling (33)

4.12.Mustard packs (33)

4.13.Washing solutions used for pathogenic microorganisms (34)

4.14.Mousse for rapid relief from irritation, itching, burning and sensitivity

associated with chickenpox (35)

4.15.Injectable substance for treatment of localized adiposity (36)

4.16.Riboflavin solution for treatment of keratoconus (36)

4.17.Dentistry products with aluminum chloride used in haemostasia (37)

5.BORDERLINE MEDICAL DEVICE – BIOCIDES (38)

Introduction (38)

5.1.Hand disinfectants (38)

5.2.Insect repellent (38)

5.3.Multipurpose disinfectants (39)

5.4.Brushes and sponges for washing/cleaning nails, hands and/or harms

in hospitals (prior to surgery) (39)

6.BORDERLINE MEDICAL DEVICE –COSMETIC PRODUCTS (40)

Introduction (40)

6.1.Tooth whitening or bleaching products (40)

7.ACCESSORY TO A MEDICAL DEVICE OR A IN VITRO DIAGNOSTIC

MEDICAL DEVICE (41)

Introduction (41)

7.1.Haemodialysis water test strips (42)

7.2.Surgical instrument decontamination products (42)

7.3.Dental Water Line Disinfectants (43)

7.4.Sterilization indicators (43)

8.CLASSIFICATION (44)

Introduction (44)

8.1.Light box indicated to treat seasonal affective disorder (S.A.D) (44)

8.2.Oxygen delivery (44)

8.3.Examination gloves coated with polyhexamethylene biguanide

(PHMB) (44)

8.4.Picture Archiving and Communication Systems (PACS) (45)

8.5.Blood refrigerators, freezers and defrosters (47)

8.6.Warming blankets (47)

8.7.Products evaluating the condition of respiratory muscles (48)

8.8.Neutral electrodes for high frequency surgery (48)

8.9.Surgical instrument decontamination products (49)

8.10.Dental water line disinfectants (49)

8.11.Dental curing lights (49)

8.12.Bacterial/viral filter for use on patient undergoing pulmonary function

testing (50)

8.13.Hydrocolloid plaster for blisters (50)

8.14.Movement monitor for babies (51)

8.15.Medical devices containing silver (51)

8.16.Ethyl chloride spray for local refrigeration anaesthesia (52)

8.17.Pathogen inactivation system for platelets (53)

8.18.Pre-transfusion confirmatory tests (54)

8.19.Eye drops regulated as medical devices (54)

8.20.Wound irrigation solutions containing antimicrobial agents (55)

8.21.Contact lenses (55)

8.22.Paraffin oil for IVF/ART procedure (56)

8.23.Dental abutments (57)

8.24.Autologous Platelet Preparation System (57)

8.25.Antimicrobial Photodynamic Therapy (APDT) systems (59)

9.SOFTWARE AND MOBILE APPLICATIONS (60)

Introduction (60)

9.1. A mobile application for processing ECGs (60)

9.2. A mobile application for the communication between patient and

caregivers while giving birth (61)

9.3. A mobile medical application for viewing the anatomy of the human

body (61)

10.APPENDIX (62)

10.1.Products currently qualified as medical devices according to

MEDDEV 2.1/3 rev 2 (62)

10.2.Products qualified as accessory to medical devices according to

MEDDEV 2.1/3 rev 2 (62)

10.3.Products currently qualified as medicinal products according to

MEDDEV 2.1/3 rev 2 (62)

10.4.Products qualified as medical devices incorporating a medicinal

substance with ancillary action according to MEDDEV 2.1/3 rev 2 (62)

11.INDEX (63)

I NTRODUCTION

1.Borderline cases are considered to be those cases where it is not clear from the

outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the Directives by their scope. Where a given product does not fall within the definition of medical device or is excluded by the scope of the Directives, other Community and/or national legislation may be applicable.

2.Classification cases can be described as those cases where there exists a difficulty

in the uniform application of the classification rules as laid down in the MDD (or where for a given device, depending on interpretation of the rules, different classifications can occur).

3.There may be cases where ‘claims’ of a medical nature are made for certain

products, where those claims cannot be substantiated by technical, clinical and scientific data. If there is insufficient clinical, technical and scientific data to support the claims made, the product would not meet the requirements of the medical device directives and therefore may not be CE marked as a medical device. For such products no medical claim can be made.

4.Defining a given product as a medical device and interpretation of the

application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market.

5.Different interpretations of Community legislation occur, and, can put public

health at risk and distort the internal market. Both issues are of great concern to Member States and the Commission. Therefore, the Commission finds it important to facilitate a dialogue among regulators and industry where diverse interpretations exist.

6.To this end, the working party on borderline and classification comprised of

Commission services, experts of Member States and other stakeholders meet on

a regular basis to discuss borderline and classification cases in order to ensure a

uniform approach. The borderline and classification meeting’s primary aim is to provide for a forum to exchange opinions, and, possibly reach consensus.

7.This manual represents the views agreed in this group on products, or categories

of products, which have raised doubts. The Commission, Member States and other stakeholders concluded that guidance is needed which goes beyond abstract rules and addresses their actual application.

8.However, please note that the views expressed in this manual are not legally

binding, since only the European Court of Justice (“the Court”) can give an authoritative interpretation of Community law.

9.This manual does not relieve national competent authorities from their

obligation to render decisions in these areas for any individual product, on a

case-by-case basis. National authorities, acting under the supervision of the courts, must proceed on a case-by-case basis, taking account of all the characteristics of the product.

10.Therefore, this manual shall not “prescribe” which regulatory framework

applies or how the classification rules must be applied by national authorities.

Rather, it shall serve as one out of many elements supporting the national competent authorities in their case-by-case decision on individual products.

11.In particular, this manual does not deprive a national authority to consult with

colleagues from other regulated sectors concerned in order to reach a complete view on all aspects related to a given product.

12.This manual will be updated in the light of the outcomes of the discussions of the

working party on borderline and classification issues.

1.M EDICAL D EVICE/I N VITRO DIAGNOSTIC MEDICAL DEVICE – MEDICAL INTENDED

PURPOSE

Introduction

According to article 1 (2)a MDD“‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;”

According to article 1 (2)b IVDD “‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

— concerning a physiological or pathological state, or

— concerning a congenital abnormality, or

— to determine the safety and compatibility with potential recipients,

or

— to monitor therapeutic measures.”

From this definition it follows that in order to fall within the definition of an in vitro diagnostic medical device, the product must also meet the definition of a medical device.

It is suggested to consult MEDDEV 2.1/1 for more detailed guidance on the interpretation of the definition of “medical device” and MEDDEV 2.14/1 for more detailed guidance on the interpretation of the definition of “in vitro diagnostic medical device”.

1.1.Light box indicated to treat seasonal affective disorder (S.A.D)

- Background

The product in question is a light box that emits bright light and the manufacturer states that light therapy is ‘a convenient and effective way of compensating for the lack of light without resorting to medication’. The manufacturer also states: ‘in autumn and winter, the seasons with the least sunlight because the days are shorter, increased symptoms resulting from light depravation may be experienced. Even standard artificial lighting in buildings cannot compensate for a shortage of natural light. The consequences of this may be depression, lack of drive, interrupted sleep and melancholia – the typical autumn winter blues’.

- Outcome

These statements are effectively claims for treatment of seasonal affective disorder (S.A.D.), which is a generally recognised medical condition, and therefore this product is considered a medical device.

For the classification of this product see paragraph 8.1.

1.2.AB0 and Rhesus (D) blood grouping intended for diet purposes

- Background

These products are tests for AB0 and Rhesus (D) Blood Grouping, which is sold through the internet and which is used by lay persons in the home environment.

The manufacturer states the following: HOME-KIT, For in Vitro Diagnostic Use, Not for Bed-Side Testing; and currently in the text, which describes interpretation of the result, the manufacturer states NOT FOR CLINICAL USE. The manufacturer has stated that the main reason and purpose of the tests is educational. It is indicated that the product enables the user to ascertain their blood group in order to determine whether a specific (food) diet should be followed. This decision was not related to following a specific diet for medical purposes.

- Outcome

According to the information given by the manufacturer, it is concluded that even though it can be argued that this product fits some parts of the definition of an in vitro diagnostic medical device, it does not meet the definition of a medical device. As the definition on in vitro diagnostic medical device (Article 1 (2) b IVDD) reads “‘in vitro diagnostic medical device’ means any medical device, the product must also meet the definition of medical device.

It can be concluded that as the intended purpose of this product can not be qualified as a medical purpose as described in definition of a medical device (Article 1 (2) a MDD), this product is not an in vitro diagnostic medical device. The product in question is not a blood typing test for a medical purpose.

This conclusion is reached in the light of the information provided by the manufacturer. It would be necessary to check if these statements are correct, and, consequently do not contain a deceptive and misleading labelling. Therefore, no reference to in vitro diagnostic medical device (e.g. 'for in vitro diagnostic use') can be made. Also, as the product is intended to be used by lay persons, there is a need for a strong and clear disclaimer which is understandable for lay users; i.e. a statement that the test results cannot be used for transfusion purposes or for blood group determination for medical purposes. It has to be noted that only a statement that the product is not a medical device can not constitute a reason to escape from the Directive and to avoid the CE marking if the criteria of the definition of a medical device are satisfied.

1.3.Pharmacy compounders

- Background

Pharmacy compounders may be used in a hospital pharmacy or in an industrial environment. They are products that are intended for the production of fluids for administration to a patient, usually as intravenous fluids (IV fluids) for administration parenterally. They are intended to be used by clinical nutritionist specialists and pharmacists. They mix a number of ingredients that are subsequently administered to the patient. These fluids may be nutritional solutions or pharmaceuticals. They may also be used for compounding formulas for cardioplegia, hydration, fluid drugs and renal replacement therapy.

The issue is whether pharmacy compounders are medical devices, particularly if the compounder is specifically intended to be used by clinical nutritionist specialists and pharmacists to correctly prescribe nutritional solutions for Total Parenteral Nutrition.

- Outcome

Pharmacy compounders are regarded as processing equipment and should not be qualified as medical devices. The compounder is only used for mixing the solution to be administered to patients, but it does not administer itself anything to a patient. It should therefore not be qualified as a medical device.

1.4.Dental disclosing products

- Background

Dental disclosing products are intended to ‘disclose’ plaque, i.e. to highlight the areas around the teeth where the plaque is in order to aid its removal. There may be claims to ‘aid oral hygiene’, to ‘aid correct brushing regimes’ or simply to identify the plaque for its removal.

Dental disclosing products may be in the form of solutions, tablets or an applicator containing the solution and may be intended for use by dentists or by individuals at home.

The question is to whether these products should be qualified as medical devices, or whether they are simply intended for oral hygiene and therefore shall not be considered as medical devices.

- Outcome

Although in severe cases, in addition with other contributory factors, plaque may lead to dental decay or gum disease, plaque is not considered to be a disease in its own right. Therefore dental disclosing products, intended to disclose plaque in order to help its removal, cannot be qualified as medical devices.

1.5.Mixer

- Background

The product is a Thermomixer (mixer) intended to control the temperature of (and mix) liquids in closed micro test tubes and micro test plates. The manufacturer claims that this mixer is specifically intended for the preparation and processing of samples from the human body within the scope of in-vitro diagnostic applications, in order to allow the in-vitro diagnostic medical device to be used as intended. Therefore the manufacturer considers this Thermomixer, being an in-vitro diagnostic accessories, to fall within the scope of Directive 98/79/EC.

- Outcome

MEDDEV 2.14/1 rev.1, states that "if, however, the product does not in fact possess specific characteristics that make it suitable for one or more identified in vitro diagnostic examination procedures, then the manufacturer is not free to bring it within the scope of the IVDD merely by affixing the CE marking to it. In other words, a manufacturer is not able to bring within the scope of the IVDD a product that, in reality, is a piece of general laboratory equipment simply by affixing the CE mark to it".

For example, the point 4 of MEDDEV 2.14/rev.1 mentions that laboratory centrifuges are not usually considered to fall within the scope of the IVD directive.

According MEDDEV 2.14/1 rev.1, the fact that this mixer is intended by the manufacturer to be used especially for in vitro diagnostic procedures is not sufficient to qualify it as an IVD medical device, if this mixer does not possess specific characteristics that make it suitable for one or more identified in vitro examination procedures.

If this mixer possesses such specific characteristics, the manufacturer will have to demonstrate these specific characteristics and the link with one or more identified in vitro examination procedures.

This case is similar to the cases of pipettes or glass slides, considered as products for general laboratory use, already published in the manual.

On the basis of the above this mixer could not be considered as an in vitro diagnostic medical device.

1.6.Non-corrective contact lenses with a medical purpose

- Background

In general, non-corrective contact lenses (commonly known as ‘plano’ lenses) are not considered to be medical devices as they have no corrective function.

Some non-corrective contact lenses, coloured or not, however may have a medical purpose. They serve to treat a number of congenital or traumatic conditions. They are often used in clinical practice or post-surgical setting as a medical prosthesis.

Examples of non-corrective contact lenses with medical purpose are:

?UV blocking contact lenses that help protect against transmission of harmful UV radiation to the cornea and into the eye so as to alleviate photophobia as seen in albinism.

?Contact lenses for therapeutic use as a bandage lens for the following acute and chronic ocular conditions:

-For corneal protection in lid and corneal abnormalities such as entropion, trichiasis, tarsal scars and recurrent corneal erosion. In addition they are indicated

for protection where sutures or ocular structure malformation, degeneration or

paralysis may result in the need to protect the cornea from exposure or repeated

irritation;

-For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, and postkeratoplasty,

-For use as a barrier during the healing process of epithelial defects such as chronic epithelial defects, corneal ulcer, neurotrophic and neuroparalytic keratitis,

and chemical burns;

-For post surgical conditions where bandage lens use is indicated such as post refractive surgery, lamellar grafts, corneal flaps, and additional ocular surgical

conditions;

-For structural stability and protection in piggy back lens fitting where the cornea and associated surfaces are too irregular to allow for corneal rigid gas permeable

(RGP) lenses to be fitted. In addition the use of the lens can prevent irritation and

abrasions in conditions where there are elevation differences in the host/graph

junction or scar tissue.

- Outcome

All the above are recognised medical conditions and therefore non-corrective lenses, coloured or not, which have the above mentioned functions are considered to be medical devices on the basis that they prevent, monitor, treat or alleviate disease.

Manufacturers of such products must, however, clearly indicate the specific intended medical purposes for these non corrective contact lenses both on the packaging / labelling and in the instructions for use. Non corrective contact lenses without specific claims (such as those listed above) would be regarded as having no medical purpose and therefore not medical devices.

1.7.Biofunctional clothes

- Background

Bio functional clothes or "therapeutic clothes" consist of clothes (e.g. socks, leggings, pyjamas, undershirts…) impregnated with silver and brown algae extract. These clothes are presented as having anti-bacterial, anti-microbial, breathable, thermal regulating and anti-odour properties. According to the manufacturer, the silver ions (positively charged) integrated into the fiber

reduce the microbial growth in the fabric and inhibit microbial growth on the skin, and the brown algae extract protects against rash act by neutralization of neuromediators and vasodilatator agents responsible for flushing. The intended use of these clothes is to prevent inflammatory crisis of atopic dermatitis.

The main mode of action described by the manufacturer is the creation of a physical barrier that prevents the contact of sensitive skin with the outside and other tissues potentially sensitizing, creating an environment helping to the attenuation of skin conditions. The actions of silver and algae extract were presented as an ancillary action. The product was presented as a Class I medical device.

- Outcome

The clothing in itself can not be considered as a medical device unless it achieves a specific medical purpose. Silver is a medicinal substance, presented as having anti-microbial properties. The combination of clothes with a medicinal substance might not be qualified as a medical device.

In addition, the intended use described by the manufacturer, prevention of inflammatory crisis of atopic dermatitis, is likely to be achieved by pharmacological or immunologic means and linked to the presence of silver and algae extract. Therefore the clothes would not be considered as a medical device, based on the determination of the principal mode of action.

In case the clothes would have in themselves a medical purpose and the principal mode of action would not be achieved by metabolic, pharmacologic or immunologic means, the product might be seen as a medical device. However in that case, the medical device would fall in Class III under rule 13, due to the combination with a medicinal substance.

1.8.System for the determination of bacterial contamination in blood products

- Background

The bacterial contamination of blood components represents a high infectious risk in blood transfusion, particularly for platelets concentrate. In order to estimate the bacterial contamination, manufacturers have developed some bacterial detection systems near the time of blood collection. A new system has been developed based on the detection and identification of a wide spectrum of common pathogenic bacteria. Following the identification, a direct count is obtained by cytometry.

- Outcome

These devices are intended to reduce the risk of transfusion reaction due to the bacterial contamination. The system is providing information regarding the safety of blood donation and therefore should be qualified as an in vitro diagnostic medical device.

1.9.Independent in-vivo dosimeters

- Background

In vivo dosimetry systems are used in radiotherapy to monitor the radiation dose received by the patient during a radiotherapy treatment. The device consists in a semi-conductor detector placed on the patient's skin and an electrometer placed in the control room where the physicians control the radiotherapy equipment. When performed early in treatment as an additional measure, the in vivo measurements of the radiation dose are an additional safeguard against setup, calculation or transcription errors. If the dose delivered to the patient is higher than the calculated dose, the system, independently of the radiotherapy equipment, can alert the physician, allowing him to act on the treatment.

- Outcome

Even if the in-vivo dosimeter is independent of the radiotherapy equipment, it can be considered that it is used to control the performance of the radiotherapy device. Therefore the in-vivo dosimeter should be qualified as a medical device. The in vivo dosimeter controls the performance of an active device intended to emit ionizing radiation and therefore should be classified as Class IIb, according to rule 10.

1.10.Gallipots

Gallipots are containers usually made from metal or plastic. They may be sterile or non sterile and may be disposable. They are intended to be used to contain various items including medicinal products or disinfectants for antiseptic fluids to scrub the incision area prior to surgery. They are defined variously as "a small glazed pot used by apothecaries for medicines, confections, or the like1", as "a small glazed earthenware jar formerly used by druggists for medicaments2", and as "a small usually ceramic vessel with a small mouth; especially: one used by apothecaries to hold medicines3".

- Outcome

Gallipots do not meet the definition of a medical device: They do not diagnose, prevent, monitor, treat or alleviate disease, diagnose, monitor, treat or alleviate or compensate for injury or handicap or investigate, replace or modify the anatomy or physiological process. Nor do they fit the definition of an accessory to a medical device. Therefore Gallipots are not considered to be medical devices or accessories to medical devices.

1.11.Shoe covers

- Background

On the EU market there are shoe covers sold at hospitals used for different purposes :

1 Source: https://www.wendangku.net/doc/8a5621562.html, Unabridged (v 1.1)

2 Source: The American Heritage? Dictionary of the English Language, Fourth Edition

3 Source: Merriam-Webster's Medical Dictionary

? Shoe covers which are intended by their manufacturer to be worn by the nursing staff to limit cross contamination in operating theatre and care units.

? Shoe covers for visitors which are intended to be worn by visitors to prevent patient’s contamination when they visit a patient.

- Outcome

According to the section 3.3 of Meddev 2.1/4, the labelling of the product is crucial for its classification under the directive 93/42/EEC. “As a general rule, the principal intended purpose can be established as being the one of a medical device if the product is intended to be used in a medical context with the aim to provide protection of health and safety for the patient, regardless of whether the product aims simultaneously to protect also the user. Where a product is mainly intended to protect the person using it, irrespectively whether in a medical environment or not, it falls under Directive 89/686/EEC.”

Consequently, shoe covers which are specifically intended by their manufacturer to be used in operating rooms, intensive care units or immunodepressed patients to protect the patient from potential contamination are medical devices. In application of rule 1, they are in class I.

In this case, shoe covers are considered as being similar to surgeons gowns and hats.

On the other hand, shoe covers for visitors even in a hospital are products of control of environment.

1.1

2.Urine Diverter / Funnel Element for Mid-Stream Urine Collection

- Background

There are a number of mid-stream urine collection kits on the EU market. In general, these products consist of a specimen receptacle and a urine diverter / funnel element. They are usually packaged together in a ‘kit’ and in general the funnel part is not attached to the specimen receptacle in the kit. The user puts the two parts together, produces the sample, then removes the ‘funnel’ and closes the specimen receptacle.

The specimen receptacle is an IVD medical device as it is intended for the primary containment and transport of the urine sample.

The question arose as to the qualification of the urine diverter or ‘funnel’ and whether it is

a general medical device (Class I) or an IVD medical device.

Some of these ‘funnels’ are intended to be held away from the body, whilst others are intended to be applied to the body. Some of these have been specifically designed for female use and this can be seen in their shape and form. In the majority of these cases the intention is for the ‘funnel’ to be held against the body whilst the urine specimen is collected.

- Outcome

The funnel / diverter itself does not fit the definition of an IVD medical device: it does not directly diagnose or provide information. It has no diagnostic function in itself. It therefore cannot be an IVD medical device in its own right, but is regarded as an accessory to the specimen receptacle.

Directive 98/79/EC states in Article 1.2 (c) that for the purposes of the definition of an accessory, invasive devices or those which are ‘directly applied to the human body’ are not considered to be accessories to IVD devices, therefore the ’funnel’ / diverter cannot be considered to be an accessory to the specimen receptacle.

MEDDEV 2.14/1 states that specimen receptacles which come into contact with the patient fall within the MDD and not the IVDD. It also reiterates Article 1.2 (c) of the Directive and states that devices which are made available with IVD devices and which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC are not considered to be accessories to IVDs and come within the scope of Directive 93/42/EEC.

Therefore, where the funnel / urine diverter is intended to be directly applied to the human body for the purpose of obtaining a specimen (within the meaning of Directive 93/42/EEC) it shall not be an accessory to an in vitro diagnostic medical device but it will

be a Class I medical device. The intended direct application to the female/male body for obtaining the specimen is demonstrated by the instructions for use, the labelling and/or other information provided by the manufacturer.

1.13.Air purifiers / Air decontamination units / Mobile air decontamination units

- Background

There are various types of air purifiers and air decontamination products on the market. There are two main types:

-‘Stand alone’ / mobile units which are intended to purify or decontaminate the air in individual rooms or areas, which may be moved from room to room in accordance with the perceived need to purify or decontaminate the air in the room. They stand in the room and function independently. They are not connected to individual patients directly (e.g. via the use of a mask). These may or may not include filters.

- Units which are installed into the fabric of the healthcare institution, supplying purified / decontaminated air through pipe works that are part of the fabric of the building, into specific rooms /areas. Filters may also be used within the systems.

The claims for these products vary from ‘purifying’ the air to ‘decontaminating’ the air; however in general they are intended to remove allergens (dust, pollen etc) and / or to remove bacteria from the air in a specific room or area.

Some of these systems contain filters in order to remove particulates in the air whilst others claim to destroy airborne micro-organisms.

In both cases the purified air is supplied into rooms and not directly connected to individual patients (e.g. via a mask) nor to breathing machines (which are directly connected to a patient).

In hospitals, these systems for air decontamination are used to reduce infection risks in intensive care units and operating theatres. They include Burnt units or systems comprising a mobile air decontamination unit and a mobile deployable room put directly above the patient which is intended to protect burnt patients or immuno-compromised patients from air contamination.

The question has arisen as to whether such products are considered to be medical devices, since it is claimed that they reduce infection risks to patients or protect patients from airborne contaminants.

- Outcome

These products are intended to ‘control the environment’ by removing allergens or microbial contamination from the air. They do not act directly on an individual patient and there is no direct contact with an individual patient. In order for a product to be a medical device, the device must have a direct association with the individual patient.

Although maintaining clean air may contribute to keeping a patient in an appropriate environment, this is not considered to be a ‘medical purpose’. Air is part of the environment of the patient and its cleanness is necessary in a similar way as for surfaces, walls, floors and other objects which also need to be cleaned and disinfected.

Since these products do not fulfil the definition of a medical device, they are not considered to be medical devices, but are rather products for the general environment.

1.14.Wigs and head scarves

- Background

Both wigs and head scarves are routinely used by people for aesthetic reasons. They may also be used by patients undergoing chemotherapy or suffering from alopecia (hair-loss) from other causes.

The question arose whether wigs and head scarves intended for such patients would be regarded as medical devices on the basis that they may protect the head, reduce physical or emotional effects of hair loss and so on.

- Outcome

Wigs and head scarves are primarily intended for a cosmetic purpose, i.e. to improve or change the appearance of the wearer.

They do not treat or alleviate any specific medical conditions and do not fit the definition of a medical device. They are therefore not qualified as medical devices.

1.15.Blood irradiation indicators

- Background

Lymphocytes contained in the blood components can bring to Transfusion Associated Graft-versus-Host Disease (TA-GvHD) in specific cases. Lymphocytes may be deprived of the possibility of multiplication through the use of irradiation. Therefore, for example red cells for intrauterine transfusion and whole blood for exchange transfusion in neonates should be irradiated prior transfusion.

Blood irradiation indicators provide information as to whether the blood products have been irradiated and protect from repeated irradiation of those products.

According to instruction for use, indicators only indicate that irradiation has occurred, while they do not measure the dose from an irradiator.

The manufacturer of the above mentioned indicators has placed these products on the market as class I medical devices.

- Outcome

The blood irradiation indicators simply show that blood product has been irradiated. They do not affect the irradiation process and only provide additional information to the user.

In this connection, blood irradiation indicators do not fulfil the definition of a medical device laid down in Article 1(2)(a) of Directive 93/42/EEC; therefore they are not considered to be medical devices.

Blood irradiation indicators cannot be considered to be accessory to a medical device because they are not intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

1.16.Odour neutralizers

- Background

Odour neutralizers, that may be presented in a spray form or as oil, are products used for the control of odours generated by the ostomy devices. The spray is intended to neutralize odours in room where in use ostomy equipment is present, while the oil is intended to be instilled in ostomy pouches.

These products are intended to improve the quality of life of people holding ostomy pouches by controlling the odours.

- Outcome

It is considered that these products have no medical purpose and therefore cannot be qualified as medical devices.

The spays are not considered to be medical devices – they are intended to be used in a room and do not fit the definition of a medical device.

The oils meet the definition of an accessory to a medical device only when these articles are intended specifically by their manufacturer to enable the pouches to be used in accordance with their intended purpose, as specified by their manufacturer, according to the definition of accessory in Article 1 par. 2(b) of Directive 93/42/EEC.

1.17.Bedwetting alarm

- Background

A bedwetting alarm is a device intended to be used as a treatment of nocturnal enuresis. Each device has a moisture sensor component and an alarm component. A moisture sensor snaps onto underwear. The alarm sounds at the first sign of moisture, and interrupts the wetting process. The bedwetting alarm conditions the user to timely recognize bladder fullness, and awaken before wetting occurs.

- Outcome

When such devices are intended for treatment of nocturnal enuresis, which is generally recognized as medical condition, they should be qualified as a medical device. Such bedwetting alarm devices should be classified as Class I under rule 12 of Annex IX of the Directive 93/42/EEC.

***

2.BORDERLINE IN VITRO DIAGNOSTIC MEDICAL DEVICE

Introduction

The definition of in vitro diagnostic medical devices reads as follows:

Article 1 (2) b IVDD “‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: — concerning a physiological or pathological state, or

— concerning a congenital abnormality, or

— to determine the safety and compatibility with potential recipients,

or

— to monitor therapeutic measures.”

From this definition it follows that in order to fall within the definition of an in vitro diagnostic medical device, the product must also meet the definition of a medical device. Article 1 (2)a MDD “‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;”

Other relevant provisions are:

Article 1 (2) b IVDD “Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.”

Article 1 (2)b IVDD “Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;”

It is suggested to consult MEDDEV 2.14/1 for more detailed guidance concerning in vitro diagnostic medical devices.

2.1.Sample receptacles and sampling devices which are intended to be used for the

collection by the lay user of samples, which are subsequently examined by third persons.

- Background

The products in question are IVD kits which are being supplied to the public for a variety of medical conditions including tests for food allergies and infections such as Chlamydia. These tests are being supplied by post to members of the public in the following manner:

The patient orders the kit from the company concerned and the kit is despatched to him. The kit contains the required equipment to take a sample. The patient is instructed to take the sample (for example, usually a urine sample or blood sample – either via a lancet, or they are advised to take their kit to their doctor for a blood sample to be taken). The sample is then placed in some type of storage container. Once the sample is obtained, the patient is instructed to send it back to the company supplying the kit. The patient is then supplied with the result of the test, indicating whether or not they have a positive result. None of these activities involve healthcare professionals.

- Outcome

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引言---------------------------------------------------5 0.1 总则-----------------------------------------------5 0.2 过程方法-------------------------------------------5 0.3 与其他标准的关系-----------------------------------5 0.4 与其他治理体系的相容性-----------------------------5 1 范围-----------------------------------------------6 1.1 总则-----------------------------------------------6 1.2 应用-----------------------------------------------6 2 规范性引用文件-------------------------------------6 3 术语和定义—---------------------------------------6 4 质量治理体系---------------------------------------8 4.1 总要求—-------------------------------------------8 4.2 文件要求-------------------------------------------8 5 治理职责------------------------------------------10 5.1 治理承诺------------------------------------------10 5.2 以顾客为关注焦点----------------------------------10 5.3 质量方针------------------------------------------10 5.4 策划----------------------------------------------10 5.5 职责、权限与沟通—--------------------------------10 5.6 治理评审------------------------------------------11 6 资源治理------------------------------------------11 6.1 资源提供------------------------------------------11 6.2 人力资源------------------------------------------12 6.3 基础设施------------------------------------------12 6.4 工作环境------------------------------------------12 7 产品实现------------------------------------------12

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XXX有限公司 医疗器械经营企业岗位职责目录 一、各级组织机构管理职能...................... 错误!未定义书签。（一）行政部质量管理职能...................... 错误!未定义书签。（二）质量管理部质量管理职能.................. 错误!未定义书签。（三）业务部质量管理职能...................... 错误!未定义书签。（四）仓储部质量管理职能...................... 错误!未定义书签。（五）财务部质量管理职能...................... 错误!未定义书签。 二、各级人员岗位职责.......................... 错误!未定义书签。（一）、企业负责人质量管理职责................. 错误!未定义书签。（二）、质量管理部负责人质量管理职责........... 错误!未定义书签。（三）、业务部经理质量管理职责................. 错误!未定义书签。 (四)、财务部经理质量管理职责.................. 错误!未定义书签。（五）、行政部经理质量管理职责................. 错误!未定义书签。（六）、验收员质量管理职责..................... 错误!未定义书签。（七）、验收员质量管理职责..................... 错误!未定义书签。（八）、验收员质量管理职责..................... 错误!未定义书签。（九）、仓库保管员质量管理职责................. 错误!未定义书签。（十）、采购员质量管理职责..................... 错误!未定义书签。（十一）、复核员质量管理职责................... 错误!未定义书签。（十二）、销售人员质量管理职责................. 错误!未定义书签。（十三）、维修养护、售后服务人员质量管理职责... 错误!未定义书签。

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医疗器械法律法规及文件体系培训试题 部门：______________ 姓名：___________________ 分数：__________________ 一、填空题 1、为了加强对医疗器械的监督管理，保证医疗器械的安全、有效，保障人体健康和生命安全，制定《医疗器械监督管理条例》。 2、为规范医疗器械分类，根据《医疗器械监督管理条例》制定《医疗器械分类规则》，及局令15 号。 3、医疗器械是指：单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需的软件。 4、《医疗器械生产企业许可证》分正本和副本，正本、副本具有同等法律效力________ ，有效期为 5 年。 5、《医疗器械生产企业许可证》变更分为许可事项变更和登记事项变更。 6自2011年_7_月—1_日起，生产企业申请无菌医疗器械首次注册和重新注册时，应当按要求提交经检查合格的《医疗器械生产管理规范检查结果通知书》—，其他医疗器械的质量管理体系检查按现有规定进行。 7、为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定《医疗器械注册管理办法》。 8、医疗器械标准分为国家标准、行业标准和注册产品标准。 9、医疗器械临床验证的范围：同类产品已上市，其安全性、有效性需要进一步确认的医疗器械。 10、公司质量手册代码为QM ，程序文件代码为PR ，记录文件代码为 JL __ 。 二、简答题： 1、公司管理文件总共有几类，分别为哪些？ 8类：组织结构与人员管理；厂房设施设备管理，物料管理，卫生管理，验证管

30理，生产管理，质量管理，销售管理 2、医疗器械注册证书中哪些内容发生变化，生产企业应当自发生变化之日起日内申请变更重新注册？有五种内容发生变化，1型号规格、2 生产地址；3 产品标准；4产品性能结构及组成； 5 产品适用范围 3、《医疗器械监督管理条例》第五条国家对医疗器械实行分类管理。请简述第一类、第二类和第三类医疗器械各指的是哪类医疗器械？ 第一类：常规管理，足以保证其安全性，有效性的医疗器械第二类：对其安全性，有效性应加以控制的医疗器械第三类：植入人体用以支持维持生命对人体具有潜在危险，对其安全性，有效性必须严格控制的医疗器械。

【医疗器械监督管理办法】《医疗器械监督管理条例》

【医疗器械监督管理办法】《医疗器械监督管理条例》 《医疗器械监督管理条例》 医疗器械监督管理条例（国务院令第650号） （2000年1月4日中华人民共和国国务院令第276号公布20XX年 2月12日国务院第39次常务会议修订通过） 第一章总则 第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。 第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。 第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。 第四条国家对医疗器械按照风险程度实行分类管理。 第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器

械。 第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。 第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。 评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。 国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。医疗器械分类目录应当向社会公布。 第五条医疗器械的研制应当遵循安全、有效和节约的原则。国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。 第六条医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。 一次性使用的医疗器械目录由国务院食品药品监督管理部门会同国务院卫生计生主管部门制定、调整并公布。重复使用可以保证安全、有效的医疗器械，不列入一次性使用的医疗器械目录。对因设计、生产工艺、消毒灭菌技术等改进后重复使用可以保证安全、有效的医疗