HAVE YOU BEEN FOLLOWING THE GUIDANCE DOCUMENTS?

Guidance documents, just like international standards, are non-binding but useful tools to help the relevant parties interpret regulations. Even though the main framework of regulations must be clear and understandable by every relevant party, that is not always the case. Hence, the importance of being up-to-date with guidance documents from all sources has the utmost importance, especially now that the MDR extension amendment is on the way.

The Medical Device Coordination Group (MDCG) is a group that originated from 13 different subgroups with different expertise, which are appointed by the Member States. The MDCG regularly publishes guidance documents directly targeted at MDR and IVDR. In December, the MDCG group released or revised seven guidance documents, which include topics that are most anticipated, like MDCG 2022-1:21 PSUR Guidance and MDCG 2022-4 rev.1: Art. 120 Appropriate Surveillance.

The European Association for Medical Devices of Notified Bodies (TEAM NB) is an organization with only members from Notified Bodies from different countries, formed with the purpose of pursuing transparency for notified bodies in Europe. Naturally, TEAM NB is closely observing regulatory developments and publishes position papers that provide insights into the Notified Bodies’ train of thought.

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators formed with the purpose of accelerating international medical device regulatory harmonization and convergence. The strategic plan set out by IMDRF includes Pre-Market, Post-Market, and Relationships with Stakeholders, which are in perfect alignment with the other groups. The IMDRF already has very comprehensive documents regarding the hot topics of the medical device industry.

Compliance with regulatory requirements in the medical device industry is no small feat. However, groups such as MDCG, TEAM NB, IMDRF, and many more are actively trying to help and guide the relevant parties to regulatory compliance.

Further reading:

https://www.team-nb.org/team-nb-documents/

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

https://www.imdrf.org/documents