European Union agrees new rules for approving medical devices and in vitro diagnostic medical devices

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The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner. However, the agreement is subject to the approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.
According an EU Council press release, the agreement will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market. The new rules will strengthen the surveillance of these so-called notified bodies by national authorities. They will also give these bodies the right and duty to carry out unannounced factory inspections. Notified bodies will have to ensure that they have available qualified personnel.


The draft regulations establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. This will allow manufacturers to act swiftly when concerns arise and help them to improve their devices continuously on the basis of actual data. Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices. The draft regulations also improve the availability of clinical data on devices. The protection of patients participating in clinical investigations will also be strengthened.


Also, certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities and to manufacturers.


According to the press release, the Council’s Permanent Representatives Committee will be invited to endorse the agreement probably mid-June 2016. Once the Parliament’s ENVI committee has also confirmed that it can accept the compromise the Council will be invited to confirm the agreement. Following the revision of the texts by the lawyer-linguists the two regulations will have to be formally adopted by the Council and the Parliament. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.


Responding to the new agreement, the president of the European Society of Cardiology (ESC) Fausto Pinto (Cardiology Department, Centro Cardiovascular da Universidade de Lisboa, Centro Académico Médico de Lisboa, University of Lisbon, Lisbon, Portugal) said: “The ESC welcomes this agreement and looks forward to engaging with regulatory authorities and HTA bodies in promoting excellence in patient management.”