European Union Agreement Will Lead to New Rules for Medical Devices

June 2, 2016—The Netherlands presidency of the European Council and representatives of the European Parliament announced on May 25 that they have reached a political agreement for new European Union rules on medical devices and in vitro diagnostic medical devices. The agreement is pending, subject to the approval by the Council’s Permanent Representatives Committee and of the Parliament’s Environment, Public Health and Food Safety Committee.

The Council's Permanent Representatives Committee will be invited to endorse the agreement, probably in mid-June 2016. When the Parliament’s Environment, Public Health and Food Safety Committee has also confirmed that it can accept the compromise, the Council will be invited to confirm the agreement. After 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 3 years after publication for medical devices and 5 years after publication for in vitro diagnostic medical devices.

The two draft regulations are expected to achieve a twofold aim: making 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.

Edith Schippers, Minister of Health of the Netherlands and President of the Council, commented in the announcement, “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 European Union, many of which are small and medium-sized enterprises and which employ more than half a million persons.”

According the European Council, the agreement seeks to ensure the safety of medical devices by strengthening the rules on placing devices on the market and by increasing surveillance once they are available.

Additionally, 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 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.

In the announcement, the European Council advised that 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. The Council said that 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 enhanced.

The agreements strengthen rules for high-risk devices such as implants that may require additional review 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 manufacturers.

The new European Union rules also explicitly cover certain devices without a medical purpose but with similar characteristics as medical devices, such as fillers and colored contact lenses for cosmetic purposes.

The European Council stated that the agreements seek to provide more transparency for patients and increased traceability through a central database that 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, health care professionals, and the public with comprehensive information on products available in the European Union, allowing them to make more informed decisions. Patients who are implanted with a device will be given key information on the product, including any precautions that might need to be taken. Devices will have a unique identification number to allow traceability throughout the supply chain to the end-user or patient, stated the European Council.