In December 2025 the Medical Device Coordination Group (MDCG) published a guidance introducing the EU Breakthrough Devices framework, supportin...
New MIR form – mandatory as from 1st May 2026
The European Commission has confirmed that the updated Manufacturer Incident Report (MIR) form version 7.3.1 will become mandatory from 1st May...
Guidance for Clinical Investigation Plan under MDR: Key Highlights!
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
Flowchart for determining eligibility under the extended MDR transitional period for Devices
The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional per...
Handling of Certification Gaps according to MDCG 2022-18
Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document that pr...
New MDCG guidance documents!
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...
Agenda of the MDCG and the MDCG subgroups has been released!
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Most...
New Guidance published by the Commission!
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereafter called the Medical DevicesRegulations) have...
IMPORTANT, Important … Guidance for class I manufacturer!
MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And other guidance...
Guidance on software classification & other documents
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is gr...
