What is EUDAMED? Modules, actor registration and the 27 November 2026 deadline
Four EUDAMED modules have been mandatory since 28 May 2026. Devices already on the market have until 27 November 2026. Who registers what, and what changed in Portugal.
Medical Devices briefings
Results
What does Regulation (EU) 2026/977 change for notified bodies?
From 25 February 2027, notified bodies under the MDR and IVDR must quote on defined information, keep to maximum timelines and publish their performance. What it changes for manufacturers.
Is your software a medical device? SaMD qualification under MDCG 2019-11
Whether software is a medical device depends on what you say it is for, not on the code. The qualification test under the MDR and IVDR, updated for 2025 guidance.
How to demonstrate equivalence under the MDR
Clinical data from an equivalent device can support your clinical evaluation, but the MDR sets a higher bar than the Directives did. The three characteristics, data access, and documentation.
What does an EU Authorised Representative do, and how is a PRRC different?
A non-EU manufacturer needs an EU Authorised Representative; every manufacturer needs a PRRC. What each must do under the MDR, and what EUDAMED adds from 27 November 2026.
What is a PSUR under the MDR, and who needs one?
Class IIa, IIb and III devices need a periodic safety update report. How often, how to group devices, and where it goes while EUDAMED's vigilance module is pending.
How is software classified under the MDR? Rule 11 and MDCG 2019-11
Once software qualifies as a medical device, Rule 11 of MDR Annex VIII decides its class. How the rule works, and why so little software stays in class I.
How to notify a substantial modification to an IVDR performance study
A substantial change to an IVDR performance study must be notified within one week and cannot start for 38 days. Why the MDCG 2022-20 template still applies while EUDAMED's module is pending.
Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents
Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.
Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR
If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.
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