Five weeks into our new world, and the key question is if we are settling in or are still greatly disturbed. I’d say both are happening, depending on whom you speak with.
Some companies are outing on their reality hat and have gone to work. Sweating over summer to get documents in place and build dossiers for a first time-almost right kind approach. Others, some of which have been in denial so far, are still trying to figure out a strategy to deal with the new requirements.
In both cases, the new guidance’s from the EU commission will come in handy. Most are providing some practical focus on what needs to happen. Key advice all around is to include guidance content as if it was law. Up until the moment of submission of your dossier. But again, the next day, as guidance may come out during the assessment process of your notified body. And they may well expect you to integrate solutions based on the new guidance during your rebuttals to the question rounds, so that by the time you get your CE certificate, you might be in full compliance to law and to guidance.
The latest guidance continues to include documents on EUDAMED, UDI and EMDN, the European nomenclature that will be embedded into your EUDAMED registrations, as well as on your certificate. Good to note on that subject, is that the European Commission has published a Q&A document on the EMDN. It explores what the European Medical Device Nomenclature is, how it was created and what its key principles are. It continues to explain how you get access to the EMDN. It also summarises the 7 levels of categories, groups, and types. The latter has different level of sub-types. It concludes to suggest you should always use the most granular and terminal term, so the lowest in the tree that is applicable. Read the doc: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_q-a_emdn_en.pdf and follow the embedded link to the webgate platform of the commission.
A next subject deals with Implant cards; both a guidance document and a factsheet is provided. It should be read perhaps together with the new guide on electronic IFU’s. The latter is merely confirming what we already knew, so no core developments here.
For the non-medical companies eagerly awaiting the guidance on the so-called annex XVI non-medical devices, there is good news now that the final draft has been published. Rumors are that there is not a lot of concern here, and it might move soon to publication stage.
The Joint Action on Market Surveillance of medical devices (JAMS) has recently been evaluated. This program was installed in parallel to the notified bodies starting to perform unannounced audit, as part of the immediate action plan from the EU commission following the PIP scandal. The project has resulted in improvements to the level of scrutiny which medical devices within Europe are subjected to by Competent Authorities. The regulatory systems are better equipped to maintain oversight of the medical devices sector efficiently and effectively. This has a positive impact on the safety of medical devices in Europe, and the level of confidence which patients, consumers and healthcare professionals can have in the European medical devices market. The report is available here: http://www.camd-europe.eu/wp-content/uploads/2021/05/JAMS-Layman-version-final-report-2020.pdf.
As a last point, some helpful guidance is on its way for the IVDR folks, that are struggling more than any, with only 5 notified bodies designated, and most products not being entitled to the grace period. With 11 months left, including the 6-12 months review needed by the notified body, it is a harsh regulatory situation. So, the good news is that the situation now has been formally acknowledged. The European Commission has published a joint implementation plan regarding the IVDR. The plan starts with the acknowledgement that “the implementation of the IVDR has proven to be a very challenging task for the whole sector and all concerned: stakeholders, the European Commission and Member States”.
The document lists priority areas and actions, defined in set A (essential actions) and set B (High priority), listing per section the specific actions intended. In set A, the critical points to be addressed are the contingency planning and monitoring, the availability of notified bodies, and the EU reference laboratories. These will be dealt with as high priority essentials.
Keep on breathing. Summer is there, so we all take a break. But probably not a very long one this time. Best to forget about MDR and IVDR for a little while.
Wishing you all a splendid summer break!
Qserve Group is your MedTech Partner for Regulatory, Quality Affairs and Clinical Trials.