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Revisions of Medical Device Directives

Revisions of Medical Device Directives

Ongoing revision: Regulation proposals of the European Commission

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

The revisions affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Objective

The aim of the revisions was to ensure:

  • a consistently high level of health and safety protection for EU citizens using these products
  • the free and fair trade of the products throughout the EU
  • that EU legislation is adapted to the significant technological and scientific progress in this sector over the last 20 years.

Revisions included the extending of the scope for legislation; better supervision of independent assessment bodies; clear rights for manufacturers/distributors; and stronger requirements for medical evidence.

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Impact assessment

The Commission proposals are accompanied by an impact assessment on the revision of the regulatory framework for medical devices.

Theis impact assessment:

  • describes the problems encountered under the existing legislation
  • justifies the need and the objectives of the Commission initiative
  • compares the different policy options and their impact on the medical devices sector.

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EU legislative procedure

The aforementioned proposals have been submitted to the European Parliament and the Council. In order to become EU law, the Parliament and the Council need to adopt the texts by ordinary legislative procedure.

See below for more detailed information on the revisions process at Parliament/Council level:

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Preparation of the European Commission’s proposals

After the last amendment of Council Directives 90/385/EEC and 93/42/EEC by Directive 2007/47/EC (see below), the Commission considered a fundamental revision of the regulatory framework for medical devices necessary to ensure:

  • a high level of human health and safety
  • the smooth functioning of the internal market
  • it meets the growing expectations of European citizens.

At the same time, the revisions sought to preserve the innovation-friendly approach of the regulation.

Public consultation

In 2008, the Commission published a public consultation document (84 kB) to seek stakeholder views on the revision of the legal framework for medical devices ('recast'). The 200 responses received are contained in a summary report (Appendix 1) and the individual responses are also available.

To complement the first consultation, in June 2010, the Commission launched a public consultation on technical aspects of in vitro diagnostic (IVD) medical devices., related to the revision of Directive 98/79/EC

Previous revision: Directive 2007/47/EC

In 2005, the Commission proposed amendments to Council Directives 90/385/EEC and 93/42/EEC, which led to the adoption of Directive 2007/47/EC of the European Parliament and of the Council in September 2007.

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