High-level Conference on Medical Devices

Today, Evelyne Vermeersch is attending a full house at the High-level Conference on Medical Devices organised by the European Commission.

At Ad Hoc Clinical, we continue to closely follow the developments to support our clients with medical device & in vitro diagnostic consultancy, regulatory submissions, and clinical monitoring.

The discussions highlighted the EU MDR and IVDR upcoming revision, reflecting on the impact of these regulations. Key topics included regulatory predictability, EU-level clinical evidence, and support for breakthrough technologies, along with a reminder that effective rules should safeguard patient safety without stifling innovation.

Another important milestone is the further rollout of EUDAMED, with several modules becoming mandatory from the 28th of May 2026. 

The Clinical Investigations/Performance Studies module is still under development and expected in 2028. 

In the meantime, we continue following the well known practices, submitting studies in compliance with MDR and in line with local procedures; just with a little extra patience on the side 😉