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Medical Device Directive (93/42/EEC) - Certification Guide

Medical Devices Directive

Medical Devices Directive (MDD) has a wide scope and its purpose is to ensure free movement of safe medical devices within the EU community. The directive requires all devices to:

  • be safe for patients, users and third-parties
  • attain maximum level of performance as attributed by their manufacturers

This directive covers a number of devices which are used for diagnosis, monitoring,  and treatment of individuals.

Medical devices have been divided by the MDD into the following classes:

  • Class I: low risk devices
  • Class IIa: medium risk devices
  • Class IIb: medium risk devices
  • Class III: high risk devices

1. Directive Name

Medical Devices Directive

 

2. Directive Number & Download Link to Legal Directive

Directive 93/42/EEC can be downloaded from the following link:

Medical Devices Directive 93/42/EEC 

 

3. Notified Body (aka, Independent Assessment) Required?

Before a manufacturer can start with the required procedure to assess their product, it is important that they determine whether the said product requires self-assessment or a Notified Body needs to be involved.

Medical devices categorized under class I (low risk devices) can be assessed and self-declared by manufacturers for the safety and compliance with the Medical Devices Directive. For medical devices under class IIa, IIb and III (medium to high risk devices), however, manufacturers need to involve notified bodies to perform necessary conformity assessment procedures. The notified bodies will determine and declare the product’s compliance with the MDD.

Of utmost importance is the following stipulation:

A Notified Body must be involved in the assessment of class IIa, IIb and III of medical devices as categorized by the MDD.

 

4. Products Covered

This directive includes any medical device which performs the following functions:

 

  • 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

 

Also, the device must not rely on pharmacological, immunological and/or metabolic means to function; it may, however, be assisted by the said means.

 

5. Examples of Products Covered

Examples of products covered under the Medical Devices Directive include the following:

  • Dental instruments
  • Stethoscopes
  • Medicine measuring cups
  • Thermometers
  • Prescription spectacles and contact lenses
  • Syringes
  • Dental treatment chairs
  • Wheelchairs
  • Bandages and splints

6. Examples of Products NOT Covered

Following types of devices will not be covered by the Medical Devices Directive:

  • in vitro diagnostic devices
  • active implantable devices
  • medicines
  • cosmetic products
  • human blood, blood products, plasma or blood cells of human origin
  • devices which incorporate at the time of placement of blood products, plasma or cells, on the market, with a few exceptions, as mentioned in the directive
  • transplants or tissues or cells of human origin
  • products incorporating or derived from tissues or cells of human origin
  • transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

 

7. Enforcement & Penalties

Each EU member state is required to lay down rules on penalties for not complying with the Medical Devices Directive. Below you can find the penalties for member states Germany and the UK as an example. For penalties relevant to other specific EU member states, please consult that state's local legislation on product safety.

  • Germany - violation of the "Produktsicherheitsgesetz" (wikipedia link) can result in fines of €3,000 - €30,000 (§ 19) and imprisonment of up to 1 year (§ 20.
  • In the UK, directive violations are are covered under Section 33 HSWA offenses and can result in an unlimited fine and up to two years imprisonment.

 

8. How to Comply: Requirements & Process

Check Conformity

Firstly, manufacturers are required to check whether their product falls under the MDD. They are, then, obligated to test their low risk products for compliance with the Medical Devices Directive themselves.

For medium to high risk devices, manufacturers need to approach notified bodies to assess the medical devices and determine their conformity to the MDD before the placement of the product on the EU market.

Declaration of Conformity (contents)

The basic layout and content of a declaration of conformity are common for all directives, but may differ slightly for each directive.

The following are required by most directives:

  • Manufacturer’s name and address
  • The equipment’s description and/or serial number
  • Reference to relevant harmonized standards
  • Reference to the specifications, where necessary, by which conformity is declared
  • Details of the signatory
  • The two ending digits of the year of CE mark affixation

 

Technical Documentation

Directive 93/42/EC requires the technical file to include the following:

  • Description of the device
  • Declaration of conformity
  • Restrictions, if any
  • List of the harmonised standards, if applicable
  • Details about notified bodies, if involved
  • Results of design calculations and examinations
  • Test reports

 

Affix CE Mark

When all the necessary steps have been taken, it is time to get the product affixed with the CE mark. The mark should be placed either on the equipment, the packaging or the instructions. The letters must be vertically equal in dimensions and must not be smaller 5 millimeters. If there are other Directives which cover the product as well, the CE marking must be affixed only when all the Directives have been met.

 

9. Free Template Download

For a free Declaration of Conformity template for the Medical Devices directive, please refer to the downloads section of the page below:

Declaration of Conformity Templates

 

10. Related Directives

Following directive are related to the MDD:

  • Active Implantable Medical Devices Directive (90/385/EEC)
  • In Vitro Diagnostic Devices Directive (98/79/EC)
  • Biocidal Products Directive (98/8/EC)

 

11. Useful Links (testing Labs, further information)

Links you may find useful in gaining more information regarding the Medical Devices Directive.

Download Full Text Directive

Guidance for Manufacturers: Class I Medical Devices

FAQs