12/04/2017 0 Kommentit
New MD and IVD regulations approved
The European device regulation is changing! The European Parliament has approved the new regulation regarding medical devices and IVD devices on May 4th 2017. As the European Council has accepted regulations earliert, these will come into effect presumably by June. The transition period on medical devices is 3 years and on IVD devices 5 years.
New regulations are to modernize and strengthen legislation, to improve market surveillance and traceability, and to ensure that the design of all medical devices and IVD devices take into account the latest scientific and technical developments. The objective of the new regulation is to:
- improve the quality, safety and reliability of medical devices: Control is tightened with regard to clinical trials. The new rules also cover a number of previously unregulated aesthetic products. In addition, the IVD devices need to comply with new risk based classification guidelines;
- increase the transparency of information provided to consumers: Key product information is easy to find in the future. Further, each product is provided with a unique identifier (UDI), with which it can be found on the new European medical device database (EUDAMED);
- increase market surveillance: manufacturers must collect information on the functionalityof their equipment placed on the market. EU countries must more closely coordinated their market surveillance activities.