EUDAMED to Become Mandatory as from 28th May 2026
A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the ...
EUDAMED Training Updates and Key Implementation Timelines
Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators. ...
New Notified Body has been Designated under MDR
There has been a new notified body that have been designated under the MDR. The new notified body: NOTICE, storitve ugotavljanja skladnosti, d.o.o. is from Slovenia. This new addition brings the total number of notified bodies under the MDR to 51. More information about this notified body can be found using the following link
Deadline to Make use of New MIR Template has been Delayed
The deadline for the mandatory use of the New MIR Template has been postponed. Previously, we reported that the new MIR form would be mandatory starting November 1, 2025. However, this has now been delayed due to indications that a revised version of the form is forthcoming. The new mandatory implementation date will be four ...
COMMISSION IMPLEMENTING DECISION (EU) 2025/2078
On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which ...
Building a Compliant QMS Under EU MDR
Establishing a robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical device manufacturers operating in the European Union. The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) requires every manufacturer to implement and maintain a QMS covering the entire lifecycle of their devices—from design and development through post-market activities. While the ...
MDCG Releases Draft Guidance on Trend Reporting
The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) ...
UPDATE: Manual on Borderline and Classification
The Manual on Borderline and Classifications has recently been updated. To offer some background, this document, initially published in 2022, intends to aid manufacturers determine whether a borderline product qualifies as a medical device or an in vitro diagnostic medical device (IVD) and how it should be classified by risk. The recent update sees the ...
Medical Devices and In Vitro Diagnostics – Targeted Revision of EU Rules
The European Commission has launched a new Call for Evidence as part of a targeted initiative to streamline the EU regulatory framework for medical devices—without conducting a full impact assessment. This step builds on ongoing evaluations of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). ...
Guidance on Custom-Made Devices
The Medical Device Regulation 2017/745 defines a ‘custom-made device’ as any device which is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications. This authorised person gives specific design characteristics provided under their responsibility. Moreover, such a custom-made device would be exclusive ...
