There is progress on the two new European Union (EU) regulations on medical devices and in vitro diagnostic medical devices. On June 19, 2015, the Council of the EU (led by Latvia, at the time the holder of the presidency of the Council) agreed the substance of its negotiating stance (vis-à-vis the European Parliament (EP) and European Commission (EC)) on the two draft Regulations.
A consolidated text of the proposed new Regulation on medical devices was subsequently published based on a direct check of unclear wording and on comments received regarding technical inconsistencies in the last version. The latest available draft of the in vitro diagnostic medical devices version is now also available. Both of these documents are relatively long but necessary reading for those following this area. As a reminder, the main objective of the two draft regulations is to strengthen the rules on placing devices on the market and tightening surveillance once they are available.
The basic system of no pre-market authorization will remain. These products will continue instead to undergo a conformity assessment to establish whether they meet the applicable standards before they are placed on the market. Depending on the risk posed by a product, the assessment may involve a so-called notified body (an independent private body with specific expertise for certain types of medical devices, which assesses whether these medical devices meet the relevant standards).
The Council, however, tightened the rules for the designation of notified bodies, for the monitoring of their assessment activities by national competent authorities (public bodies) and for cooperation of those competent authorities. The new rules would also give notified bodies the right and duty to carry out unannounced factory inspections (a key area to be prepared for). On post-market surveillance, the Council added explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market.
Briefly summarizing some other areas, the draft regulations also provide for strengthened provisions on clinical investigation with a view to increase the availability of reliable clinical data on medical devices. The Council focused its efforts in particular on the protection of those undergoing clinical trials. The draft regulations also seek to provide patients with more transparency on the available devices, and increase their traceability. Further, patients who are implanted with a device would be given key information on the product, including any precautions which might need to be taken. Manufacturers of high-risk devices would have to make publicly available a summary of their safety and performance, with key elements of the clinical data.
On traceability, manufacturers of medical devices would have to fit their products with a unique device identification to ensure traceability. Manufacturers and importers of both categories of products would have to register themselves and the devices they place on the EU market in a central database. An EU portal would be set up where manufacturers would have to report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The Council was concerned to ensure that the traceability and identification rules can be implemented in practice and made changes in this area.
What happens next? The current presidency of the Council of the European Union (held by Luxembourg from July 1) will now take contact with the EP to prepare negotiations between the two institutions. The EC will also be involved. If all goes well, final texts will be agreed during the Dutch presidency in the first half of 2016. There is still some way to go on this, but this is the latest update for now.