The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.
Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.
"This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. 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", said Edith Schippers, Minister of Health of the Netherlands and President of the Council.
Strengthening the system
The agreement reached seeks to ensure the safety of medical devices by two means: by strengthening the rules on placing devices on the market and tightening surveillance once they are available.
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.
Strengthened rules for high risk devices
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.
The new EU rules also explicitly cover certain devices without a medical purpose but with similar characteristics as medical devices. This concerns for instance fillers and coloured contact lenses for cosmetic purposes.
More transparency for patients and increased traceability
A central database will be set up to create an improved system for all relevant information. It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates. In addition, it will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU. This will enable them to make better informed decisions. Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken.
Devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
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.
Source: European Council