Changes in EU law

On 26 September 2012 The European Commission has put forward proposals for two regulations aimed at improving the safety, efficacy and innovation of medical devices. The Commission's proposal consists of:

  • the proposal for a regulation on medical devices (replacing Directive 90/385/EEC concerning active implantable medical devices and Directive 93/42/EEC on medical devices);
  • proposal for a regulation on in vitro diagnostic medical devices (replacing Directive 98/79/EC on medical devices used for in vitro diagnosis).

As indicated in the press release, the main elements of the above-mentioned proposals are:

  • an extended and more transparent scope of EU legislation, including, for example, implants for aesthetic purposes and clarified e.g. for medical software. This will ensure an appropriate assessment of the safety and performance of these products before they are put on the European market;
  • closer supervision of independent assessment bodies by national authorities;
  • a wider range of powers and responsibilities for assessment bodies to ensure thorough testing and regular inspections of manufacturers, including unannounced factory inspections and sample testing;
  • clearly defined rights and obligations of manufacturers, importers and distributors, including diagnostic services and online sales;
  • extension of the medical devices database, providing public access to comprehensive information on products available on the EU market. Patients, healthcare professionals and the general public will have access to the most important data on medical devices available in Europe, allowing them to make more informed decisions;
  • easier traceability throughout the supply chain to respond quickly and effectively to safety concerns. A system of unique device identification codes will be introduced in order to increase the safety of medical devices after they have been placed on the market, to reduce medical errors and to combat counterfeiting;
  • tightening of clinical evidence requirements to ensure patient and consumer safety;
  • adapting the rules to technical and scientific progress, for example adapting safety and performance requirements for new medical technologies, such as software or nanomaterials used in healthcare;
  • better coordination between national supervisory authorities to ensure that only safe products are available on the European market;
  • international guidelines to facilitate international trade.

Press release available in full at:

KONDRAT Law Firm and Partners

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