Revisions of Medical Device Directives go into final round in Brussels: The Council, Parliament and Commission of the European Union have been negotiating the final amendments to the new European Medical Device Regulation (MDR) and the In-vitro Diagnostics Regulation (IVDR) since October 2015. In all probability, the responsible bodies will pass the new EU legal framework for medical devices and in-vitro diagnostic medical devices this year. A glance at the almost finished draft text shows the far-reaching amendments for which the medical device industry must prepare. TÜV SÜD has already set up various project teams, which are preparing the necessary changes to its own quality management system and will apply without delay for designation as a Notified Body (NB) under the new Regulations to start auditing according to the new regulatory acts in 2017. The clock is ticking – also for medical device manufacturers.
Final steps in the legislative procedure
The European Union’s discussions and voting on the “Regulation of the European Parliament and of the Council on medical devices” (Medical Device Regulation, MDR) and the “Regulation of the European Parliament and of the Council on in-vitro diagnostic medical devices” (IVD Regulation) are now entering their eighth year. After the first reading on October 22, 2013, and following two years of discussions and consultation on roughly 1,500 applications for amendments, the Council agreed on a “Common Position” on October 5, 2015. In one of the last steps of the legislative procedure, this draft of the legislative act will now undergo final discussion by the Council, the Parliament, and the Commission. After years of debate and under major political pressure, the EU’s Council of Ministers is now striving to conclude negotiations this May. According to observers, it is highly likely that the consent reached so far will last and that the parties in charge will approve the final draft. The process will then pick up speed: The draft act will be checked by the Legal Revisers and translated before going to second reading and then being passed by the EU Parliament and the Council of Ministers. The experts assume that the resolution on the new MDR and IVDR will be passed in autumn 2016.
Short periods, no “grandfather” clause
This will be the start of the final countdown, which will end on expiry of the three- or five-year transition period. This means the placing on the market of new medical devices under the previous Regulations may already become impossible in late 2019. Stakeholders who have not changed their processes and documentation to the new MDR and IVDR by then will run the risk of not receiving new certification. However, stakeholders also need to take action over medical devices that have already been registered. The drafts of the new Regulations do not include a “grandfather” clause for medical devices that are already placed on the market. Following expiry of the transition period, they may be sold for a maximum of a further five years.
Companies are adopting very different strategies to cope with the changes required under the new legislative acts. While some want to be on the safe side and strive to ensure registration sooner rather than later, others take more of a wait-and-see approach. “Experience has taught us that there will be a large number of enquiries for conformity assessment towards the end of the transition period,” says Hans-Heiner Junker (TÜV SÜD Product Service). If the audits then reveal that medical devices fail to fulfill the new criteria right away, on-time market approval may turn into a problem. “Stakeholders who want to make sure that their devices are registered on time must address the requirements of the new MDR and IVDR on time. As risk classes have been redefined, they should particularly make sure to look at each single device.” Junker signals that TÜV SÜD is ready for action as far as the new MDR and IVDR are concerned. He notes that the majority of changes that stakeholders will have to implement are already clear, and announces that at TÜV SÜD the transition is already under way: “The sooner we work with our customers to address the new requirements, the better all of us will be able to prepare and fulfill them on time.” TÜV SÜD aims to carry out the first audits under the new MDR and IVDR as early as 2017.