Medical Device Regulation

Medical Device Standards

Before a manufacturer can sell a medical device in the EU, they must meet the requirements set out in several pieces of legislation:

  • Active implantable medical devices (covers all powered implants e.g. pacemakers) 90/385/EEC
  • In vitro diagnostic medical devices (covers any medical device which is intended for in vitro testing) 98/79/EC
  • Medical devices (covers most other medical devices) 93/42/EEC.

The legislation only requires that the medical device is 'safe'. The technical interpretation of the legislation is left to (voluntary) Standards.

Manufacturers must meet the appropriate Standards, but may deviate from the their requirements as long as they can show that the overarching requirements of the legislation are met (i.e. that the device is ‘safe') - even though the Standard may not cover their particular technology. This could apply to novel technologies, for example.

Harmonised Standards

To help manufacturers, some Standards are given a special status. They are 'harmonised' and compliance with relevant parts of the standard are deemed to give a 'presumption of conformity' to the legislation

From time to time, a list of harmonised Standards is published in the 'C Series' of the Official Journal. It can also be found online on the Commission site. Manufacturers should check this regularly, so they area aware of any relevant changes. When Standards are revised there is usually a transition period, but this is not always the case.

How to Connect Standards to Legislation

As Standards do not usually cover a whole piece of legislation, a harmonised Standard also has an 'Annex Z’. This aims to match up the various clauses of a Standard with the appropriate part of legislation that gave rise to it. If a harmonised Standard is based on International Standards (e.g. IEC-ISO), it will also have an 'EN' Foreword. This shows which versions of Standards are accepted.

Important Standards for Medical Device manufacturers

Standards