This summer has been remarkable in Europe. Where normally the moderate sun is accompanied by the occasional shower, and we all have a relaxed and cool break, this year has seen long tropical and subtropical periods with hardly a drop of rain. Indicative for the equally hot and unrefreshing summer in medical device Europe land…
So what’s happening?
Notified Bodies are starting to prepare for MDR/IVDR by instructing clients on the last available MDD/AIMD/IVDD review and audit slots, on expedited and expensive reviews in the last period, etc. Generally speaking, the old regime continues till the end of 2018, and after that we are pushed to move towards the MDR. Some notified bodies have started to indicate that new submissions need to be MDR ready from now on.
Meanwhile, Medtech Europe is raising the alarms. Key points focus on include the following hurdles:
- Slow Notified Body designation process and lack of resources will be the key bottleneck
- There is no roadmap for delegated and implementing acts
- Even the basic UDI is a very complex process to manage
Realistic scenarios indicate the first Notified Bodies to be designated in Q2/Q3 2019, leaving less than a year for transition into MDR in the core transition phase, and 2 more years of grace-period under conditions that cannot always be met. Together with above mentioned reference to Notified Bodies starting to end the opportunities for early renewal of existing certification, the pressure on the assessment processes will be very high.
Whilst not all delegated and implemented acts need to be ready on short notice, a dozen or so are needed for the basic implementation. And as transition needs to start in the very near future, the uncertainty of their publications dates, besides details on the content, are bringing anxiety to stakeholders.
UDI implementation is a huge project within companies but is doable and clearly serves the purpose of enhancing traceability. As such it will be another measure towards improving patient safety. Basic-UDI however is a different story. It is introduced for regulatory purposes, linking device models to regulatory documentation and approval. As such not a UDI system, but rather a regulatory catalogue number.
The good news is, that industry has dived into implementation of the EU-MDR, and is massively getting gap assessments and implementation plans in place. Concerns raised are no longer on the concepts and intent of the new legislation, but on practical elements in its implementation.
Meanwhile, the European Commission, though their JRC Agency (Joint Research Centre), provided a key report outlining work and processes for expert panels, expert laboratories and reference laboratories. Actions are identified, including interactions with stakeholders, building a legal basis with implementing act(s), and getting the system of experts in place.
Individual Member States have also beefed up the publications. For example, MHRA provided an MDR checklist, basically identifying which party should do what, and Dutch authority provided guidance not only for industry, but also for other stakeholders such as hospitals and patients.
Brexit – deal or no deal
With 7 months and a few days to go, Brexit chances of no-deal are rapidly increasing, and latest KPMG survey indicates over 50% of Britons anticipating a NO-DEAL scenario. Following the European Commission positions in January and July on such no-deal situation, UK yesterday started to release a series of 80 papers clarifying rules for such no-deal scenario.
In summary, the following would be the current position for a no-deal scenario:
Where the UK position is factually stating the situation before and after 29 March 2019, the Commission communication is strongly urging industry to take rapid actions, as they should seriously prepare for all remaining scenarios, including the no-deal situation.
The residual Brexit scenarios with some kind of deal will likely have a transition period until 31 December 2020. In that period, UK Notified Bodies and UK certificates continue as before provided this is agreed to in the transition agreement, see for example the MHRA position on the implementation period that would be applicable in such a scenario.
So, lots of excitement, which lead even large global manufacturers to seriously worry about access to Notified Body resources and about Brexit preparations. The heat is on, and the summer of 2018 is not over yet!