European Commission proposes new regulations for medical devices

3 October 2012

The European Commission has proposed two regulations which it says will ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices [1,2].

The proposals are aimed at ensuring devices are fit for purpose, more transparent and better adapted to scientific and technological progress. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn [3].

The proposals have been submitted to the European Parliament and the Council. In order to become European Union law, the European Parliament and Council need to adopt the texts.

Health and Consumer Policy Commissioner John Dalli said, "Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must
do our best never to let this happen again. This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day.

"The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector."

The European Radiological, Electromedical and Healthcare IT Industry association, COCIR, has welcomed the move, saying new EU Regulation could significantly improve the harmonisation of the EU
regulatory framework for medical devices across Europe and bring new products to clinical use faster.

The European industry association Eucomed, however, welcomed most of the recommended measures but voiced strong concern with regards to the 'scrutiny' procedure (see MTB Europe news Eucomed voices concern over scrutiny procedure in EC proposal for medical device regulations).

Kevin Haydon, COCIR President said “It is crucial for the benefit of European citizens to accelerate the uptake of innovative medical
technology for the sustainability of healthcare systems across Europe, since we currently have an ageing population, a rise of chronic diseases, scarce healthcare workforce and an uncertain economic outlook.”

At the same time, it is essential that the regulation matches the specificities of the sector, while continuously improving but also avoiding an increase in the time to market and creating an unnecessary administrative burden. This could hamper innovation and,
as a consequence, be detrimental to European citizens who would not be able to benefit from those innovations.

COCIR believes that the current regulatory framework for its technologies is already adequate. There is however a need to modernise and strengthen it with efficient tools to enhance the traceability of the products and their critical components, harmonising EU Member States’ engagement and having a better coordination of the future regulatory framework, especially for the post-market phase.

COCIR Secretary General, Nicole Denjoy said, “As an industry, we are calling for smart and efficient regulation guaranteeing transparency, patient safety, high quality and rapid access to highly-innovative medical technology and without significant increases in regulatory fees and costs. A reliable and simple regulation with the critical support of ‘state of the art’ standards for medical devices is essential to ensure safe and equitable access to healthcare in the European Union. COCIR will continue its efforts to contribute to better regulation and is ready to continue its dialogue with European Parliament and European Council.

“This is a unique opportunity for regulators to find an efficient way to work together for smarter regulation in Europe and beyond. We welcome any initiative to strengthen the exchange of best practice between regulators as Maximum Safety is the primary goal for industry and all other stakeholders and is not only the responsibility of the regulators.”

Who will benefit?

  • Patients and consumers since all devices will have to undergo thorough assessment of safety and performance before they can be sold on the European market. Control processes are radically reinforced, but continue to ensure rapid access to innovative, cost-effective devices for European patients and consumers.
  • Healthcare professionals will be provided with better information on the benefits for patients, residual risks and the overall risk/benefit ratio, helping them make the best use of medical equipment in their treatment and care of patients.
  • Manufacturers will benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.

Main elements of the proposals

  • Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software. This will ensure that the safety and performance of these products are correctly assessed before they are placed on the European market;
  • Stronger supervision of independent assessment bodies by national authorities;
  • More powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing;
  • Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
  • Extended database on medical devices, providing comprehensive and public information on products available on the EU market. Patients, healthcare professionals and the public at large will have access to the key data concerning medical devices available in Europe, allowing them to make better informed decisions;
  • Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns. A Unique Device Identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting;
  • Stricter requirements for clinical evidence, to ensure patient and consumer safety;
  • Adaptation of the rules to technological and scientific progress, for example the adaptation of the safety and performance requirements applicable to new health technologies, such as software or nanomaterials used in healthcare;
  • Better coordination between national surveillance authorities, to ensure that only safe devices are available on the European market;
  • Alignment to international guidelines, to facilitate international trade.

The revised regulatory framework for medical devices is comprised of the following:

  • A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
  • A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).

Further information

1. For more information on the EC regulation proposals see:

3. EC web page with documents on the Revision of the medical device Directives:

3. 2009 Eucomed figures for EU 27, Norway and Switzerland:

4. MTB Europe news: Eucomed voices concern over scrutiny procedure in EC proposal for medical device regulations.


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