The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. According to the press release, the goal of these new regulations is to:

mak[e] sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit [from] innovative health care solutions in a timely manner.

The press release notes that the draft regulations will accomplish these goals by strengthening the rules on placing devices on the market and tightening surveillance once they are available. Regarding the agreement, Edith Schippers, Minister of Health of the Netherlands and President of the EU Council stated:

The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons.

Organizations such as the European Society for Cardiology and MedTech Europe have hailed the agreement as a significant step forward. Serge Bernasconi, CEO of MedTech Europe said:

The medical industry recognises the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.

If the Parliament’s ENVI Committee (i.e., the Committee on Environment, Public Health and Food Safety) and the EU Council confirm the agreement later this year, the new rules will apply three years after publication for medical devices and five years after publication for in vitro diagnostic medical devices. A draft of the new regulations is not yet available, but the press release provides the following notable details on the expected content.

Expected Impact of Draft Regulations on Device Manufacturing

  • “[F]urther tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market”
  • “[S]trengthen the surveillance of these so-called notified bodies by national authorities”
  • Give the notified bodies “the right and duty to carry out unannounced factory inspections”
  • Manufacturers will be responsible for “the follow-up of the quality, performance and safety of devices placed on the market”
  • “Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices”
  • Improved availability “of clinical data on devices”
  • Strengthen the protection for “patients participating in clinical investigations”
  • Increased checks by experts for certain high risk devices

Expected Impact of Draft Regulations on Transparency and Traceability

  • Creation of a central database for “all relevant information”
    • “It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates”
    • “It will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU”
  • “Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken”