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Regulatory Information

Standardisation in the EU is being implemented throughout Europe as the borders between Member States are eliminated and the principle of free movement of goods within the Union is on the uptake.  A 'New Approach' to standardisation was implemented in 1985 to facilitate these changing attitudes.  New legislative requirements for health and safety were put into practice along with the harmonised European standards.

The 'New Approach' directives cover a broad range of products from hot water boilers to toys.  The following directives are Of particular interest to the medical device market:

The Active Implantable Medical Device (ARWD) Directive - 901385/EF-C
The Medical Device Directive (MDD) - 93142/EEC
The In Vitro Diagnostic Device Directive (WD) - 98179/EC.

There are well over 150 harmonised standards relating to these directives and conformance with them is the easiest way to show compliance with the directives. Compliance with the directives is mandatory, while conformance with the harmonised standards is not. Where conflicts between a medical directive and a European national law arise the directive takes precedence.

Having said that, harmonised standards are not the only way to demonstrate compliance with the MDD.

The MDD requires the manufacturer of medical devices to keep a product-related, adequate and efficacious quality system. The application of the quality system must ensure that the products conform to the provisions of the NMD. All the elements, requirements and provisions adopted by the manufacturer for the quality system must be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programs, quality plans, quality manuals and quality records.

The MDD gives more flexibility to the device manufacturer in organising the company according to size, social environment, and cultural trends of countries as well as the nature of the devices than the ISO 9000 series of standards. On the other hand even ISO 9001 registration in combination with the additional requirements of EN 46001 does not fully cover the requirements of the MDD.

Additional aspects to be covered by the quality management system include:

  • technical documentation
  • reference to the essential requirements according to Annex 1 of the UDD
  • information about harmonised standards and medical device regulations
  • risk analysis labelling
  • different languages
  • post-marketing surveillance
  • reporting under the vigilance system
  • retention of certain documents.

    Useful sites related to regulatory affairs in Europe are as follows:
  • This is the main EU site but browsing through it can take a long time. Anyone looking for a particular document should go to the search page and look for it there.
  • The Eudor site can be used to order EU documents. The site has an option for searching the Official Journal of the European Community, in which all standards and directives are published.
  • This is a very user friendly site that is geared towards American companies looking to export products to Europe or to set up manufacturing sites in Europe.
  • This site is for the Medical Devices Agency, which is the UK equivalent to the FDA.

  • Further detailed information can be gained through the following organisations:

    Medical Devices Agency, Department of Health:
    Hannibal House
    Elephant and Castle
    SE1 6QT
    Tel: 0171 972 8123
    Fax: 0171 972 8103

    Medicines Control Agency, Department of Health
    Market Towers
    1 Nine Elms Lane
    SW8 5NQ
    Tel: 0171 273 0000
    Fax: 0171 273 0353

    European Medicine Evaluation Agency
    7 West ferry Circus
    Canary Warf
    EH1 4HB
    Tel: 0171 418 8400
    Fax: 0171 418 8416

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