Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Description:

The Medical Devices Directive aims to ensure the free movement of goods within the Community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices by the manufacturer.

The Medical Devices Directive defines which products fall within its field of application, it provides the essential requirements that medical devices and accessories covered by it must comply with, and it outlines the conformity assessment procedure the manufacturer must apply in order to ensure compliance with the essential requirements.

Medical Device Directive:

- The equipment should be safe and the risk should be within acceptable limits.

- The device should be designed according to the latest knowledge, the risk should be eliminated or prevented, at least given a warning.

- The equipment should meet the manufacturer's specified performance.

- The safety and performance of the equipment must be guaranteed within the life of the instrument.

- Safety and performance of the equipment in a reasonable transport, storage conditions are not affected.

- The side effects and the benefits provided by the instrument should be within acceptable limits.

Guidance on EU product safety standards for medical equipment CE certification

The Directive is only a mandatory law, it provides our equipment must be achieved to what level of safety, then how can our equipment to achieve the requirements of the instructions?

In response to this, the European technical committee issued a series of coordination standards. European Standard (EN) is a tool that helps manufacturers and users comply with directives. Standards are non-mandatory, but rather provide advice on compliance advice, especially with regard to the development of technical construction documents, so they are methodological kits, and they provide more robust evidence.

The following description of the medical device CE certification required reference to the assessment of the EU product safety standards.

Basic standards

EN ISO 13485 medical device quality management system for regulatory requirements

Application of Medical Device Risk Management to Medical Devices

- EN 980 Use of medical device label symbols

- EN 1041 Information provided by medical device manufacturers

- ISO7396-1, ISO10524-1, ISO15002 This standard is oxygen inhaler.

Reference standard

In addition to the above criteria, we must also consider the basic health and health requirements of medical device directives, as well as some basic equipment safety standards as a reference, the main reference criteria are as follows:

- EN 60601 series of active instrument standards

- EN ISO 10993 series biocompatibility

- EN ISO 11137 Series Irradiation Sterilization

- EN ISO 11607 series aseptic packaging

- EN550 / EN552 / EN554 Damp heat sterilization

- MEDDEV2.12 / 1 alert system guide

- MEDDEV2.7.1 Guidelines for the evaluation of clinical data,

Required Documents

1． General descript of the device

2． Description of intended use

3． Class of device, chosen classification rule and justification

4． Description of accessories (if applicable)

5． Description of incorporated pharmaceutical substances (if applicable)

6． Description of utilized tissues of animal origin (if applicable)

7． Planned production methods

8． Description of checks during and at the end of production

9． Responses to essential requirements

10． List of applied standards

11． Risk analysis

12． Specification of materials

13． Drawings and schematics

14． Labeling

15． Description of packaging

16． Instructions for use

17． Lifetime and/or shelf-life

18． Sterilization validation (if applicable)

19． Test reports (electrical/mechanical/biocompatibility etc.)

20． Clinical data

Appendix: CE certification of medical devices
The classification of medical device products is mainly taking into account the vulnerability of the human body, as well as the product in the design and manufacture of potential hazards. Class I covers potentially dangerous products, Class III is the most dangerous product.
Classification of Medical Device Classification: Directive 93/42 / EEC Annex IX.
1. Class I medical devices
Example: repeated use of scalpels, wheelchairs, dental polymerizer and so on
The medical device is in accordance with Directive 93/42 / EEC Annex VII.
2. Class I sterilization medical equipment
Example: disposable sterilization bandage, sterile cotton and other disposable use of Class I medical equipment
Medical devices are in accordance with Directive 93/42 / EEC Annex VII Declaration of Conformity and then evaluated in accordance with one of Annex IV, Annex V, Annex VI.
3. Class I Medical devices with measurement function
Example: Medical goniometer (Goniometer), pupil spacing meter (Interpupillary distance meter)
Medical devices are in accordance with Directive 93/42 / EEC Annex VII Declaration of Conformity and then evaluated in accordance with one of Annex IV, Annex V, Annex VI.

2. IIa medical equipment
Examples: Acupuncture needle, TENS, MRI, hearing aids, contact lenses, sterilizer, X-ray film, etc. 
Medical equipment companies are evaluated according to Directive 93/42 / EEC Annex II and can also be evaluated according to one of Annex VII and Annex IV or Annex V, Annex VI.
3. IIb medical device
Example: X-ray diagnostic equipment, blood bag, Insuline pump, electronic operating machine, Lithotriptor, Nonabsorbable suture, nonvascular stent, etc.
Medical equipment companies are evaluated according to Directive 93/42 / EEC Annex II and can also be evaluated according to one of Annex III and Annex IV or Annex V, Annex VI.
4. Class III medical devices
Examples: Absorbable Suture, Vascular Stent, Cadiacvascular Catheter, Animal Tissue Products, etc.
Medical equipment companies are evaluated according to Directive 93/42 / EEC Annex II and can also be evaluat