Brief Introduction of|
EU Council Directive 93/42/EEC
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There are three Medical Device Directives in place, the Directive of Active Implantable Medical Devices (90/385/eec), the Medical Devices Directive (93/42/EEC), and the Directive of In Vitro Diagnostic Medical Devices (98/79/ec).
In common with other New Approach Directives, the three Medical Device Directives in place include provisions for mandatory CE Marking of all products covered by them.
The scope of the notifications are as follows :
Medical Devices Directive (93/42/EEC)
- Annex II Full Quality Assurance
- Annex V Production Quality Assurance
- Annex VI Product Quality Assurance
Active Implantable Medical Devices Directive (90/385/EEC)
- Annex II Full Quality Assurance
- Annex V Production Quality Assurance
The content of this page deals only with the Medical Devices Directive (93/42/EEC).
A Medical Device is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
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 by such means. The Directive gives additional definitions of relevant devices and terms. The following products are excluded from the scope of the Directive:
- diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
- investigation, replacement or modification of the anatomy or of a physiological process.
- control of conception
- In vitro diagnostic devices
- Active implantable devices covered by Directive 90/385/EEC
- Medicinal products covered by Directive 65/65/EEC
- Cosmetic products covered by Directive 76/768/EEC
- Personal protective equipment covered by Directive 89/686/EEC
- Tissues or cells of human origin
- Viable tissue or cells of animal origin.
The Directive sets out the classification criteria for Medical Devices and outlines the appropriate conformity assessment procedures for each class of device.
The Medical Device Directive came into effect on 1st January, 1995
A transitional period, up to 13rd June 1998, within which manufacturers may choose either to apply CE Marking under the terms of the Directive or to conform to specific national regulations allowing product to be marketed only where such national regulations are accepted, is given in the Directive.
All devices being put on the market in the EU after 13rd June 1998 must
bear CE Marking.
Under the terms of the Medical Device Directive a competent authority is nominated by the Government of each member state to monitor and ensure compliance with its provisions. The Competent Authority is responsible for;
- designating Notified Bodies to carry out conformity assessment procedures.
- handling applications for clinical investigations.
- ensuring adverse incidents are reported within appropriate time scales and evaluated.
- the withdrawal of unsafe devices from the market.
- effecting the Directives into law through statutory instruments.
- ensuring only those devices bearing the CE marking are allowed onto the market.
Medical devices, bearing the CE marking, are presumed to conform to the appropriate essential requirements, unless there is reason to believe otherwise. Should this be the case, the Competent Authority will take appropriate measures which may include withdrawal from the market. The Competent Authority must inform the European Commission of any enforcement action taken.
The organization which will check whether the appropriate conformity assessment procedures have been followed is known as the Notified Body. It is a certification organization which the Competent Authority, of a Member State designates to carry out one or more of the conformity assessment procedures described in the annexes of the Directives. A Notified Body must be qualified to perform all the functions set out in any annex for which it is designated. The Directive lays down criteria for the Competent Authority to assess whether certification organizations are sufficiently qualified to act as Notified Bodies. They may do this only for organizations under its own jurisdiction. The Competent Authority must notify the European Commission of those bodies selected. These will appear in the Official Journal of the European Communities. The selection criteria ensure impartiality and expertise of prospective Notified Bodies. Periodic auditing of the Notified Body by the Competent Authority, will ensure adherence to these criteria. A Notified Body will not necessarily have to carry out every part of the testing or auditing, some aspects may be sub-contracted. In such cases, the Notified Body must retain the final and overall responsibility.
A non-EU Manufacturer's European Authorized (Authorised) Representative is the one who will represent the manufacturer to deal with the CE Marking vigilance authorities from the 27+3 EEA (EU & EFTA) Member States. It is required by the EU legislation that a non-EU manufacturer of Medical Devices must print its European Authorised Representative´s name, address & contacting details on the packaging/labeling of the medical devices sold onto the EEA (EU & EFTA) market. The authorities from any of the 27+3 EEA (EU & EFTA) Member States may call the Authorized Representative up for CE Marking vigilance at any time and the Authorized Representative must respond immediately and properly within the permitted time. Click here to learn more ->>
Conformity Assessment Procedures
The conformity assessment procedures are the routes available under the Medical Devices Directives, for manufacturers to demonstrate that their devices meet the Essential Requirements, thus enabling the CE marking to be affixed to the device. Having classified the device according to its properties, function and intended purpose, devices will be assigned to one of 4 Classes;
||Low risk devices |
|Class IIa and Class IIb
||Medium risk devices |
||High risk devices |
The main purpose is to allow the strictest controls to be applied only to those devices which present the greatest risk to health or safety. Conformity assessment routes and details on the various options available to the manufacturer for different classes of devices are set out in the Directive.
In assessing the Quality Management System element in conformity assessment some notified body has adopted the EN 46000 series of standards, particular requirements for Medical Device manufacturers' in addition to the ISO 9000 Series.
GUIDE TO CE MARKING
|Classify your products according to Annex IX of
Directive. Click here to learn more...|
|Decide on your conformity assessment route (Annexes). The following options are open to you.|
Sterile / Measuring
|Annex VII + Annex V|
for Sterile /
|Class II a
Annex VII + V
Annex VII + VI
|Class II b
Annex III + V
Annex III + VI
Annex III + V
||Appoint an Authorized Representative domiciled in the EEA (EU & EFTA) member states. Register your products if required.|
|Follow conformity procedures details in the Directive.|
|Proper labeling and affix the CE Marking on the product(s).|
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Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-
- Does my product need CE Marking in order to be sold/exported on/to the European Market?
- How to obtain CE Marking for my product?
- How can Wellkang Consultant Firm help me to obtain CE Marking for my product?
- Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
- Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish.
- Complete list of all CE Marking Directives and Guidelines to Directives
- Complete list of all (more than 1000) Notified Bodies for CE marking
- Complete list of all European and/or international standards related to CE marking
- 85/374/eec: Directive of Liability for Defective Products (for all products)
- 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
- 2000: (Proposal for a new) General Products Safety Directive (for all products)
- 92/59/eec: Directive of General Products Safety (for all products)
- 93/68/eec: "CE Marking" Directive (for all products)
- 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
- Guide to Implementation of directives based on new approach & global approach (for all products)
- 73/23/eec: Directive of Low Voltage Electrical Equipment
- Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
- 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
- 87/404/eec: Directive of Simple Pressure Vessels
- 88/378/eec: Directive of Toys & Annex I, II, ... IV
- 2001 Framework of implementation of 88/378/eec: Directive of Toys
- 89/106/eec: Directive of Construction Products
- 2001 Guidance to 89/106/eec Directive of Construction Products
- 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
- Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
- Technical-Aspects relating Directive of Electromagnetic Compatibility (EMC) 89/336/eec
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
- 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan
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