On Wednesday 25 May the EU institutions reached agreement on the draft texts for the revised Medical Devices Regulation and In Vitro Diagnostics
Regulation, which will together replace the existing three Directives regulating devices, active implantable devices and in vitro diagnostics.
The agreed 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 of innovative health care solutions in a timely manner.
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.
- 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.
- 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.
- 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.
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.