The European Commission has confirmed that the updated Manufacturer Incident Report (MIR) form version 7.3.1 will become mandatory from 1st May...
EU to become the first market again? Significant reduction of MDR/IVDR burdens ahead!
On December 16, 2025, the European Commission published a legislative proposal substantially revising the Regulations 2017/745 (MDR) and 2017/7...
Your Voice Matters: Help Shape the Future of EU Medical Device & IVD Regulations!
The European Commission has opened a consultation on the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic ...
New MIR Form (Version 7.3.1)
The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
Change of classification Reduced risk of SARS-CoV-2
The European Commission made an announcement for manufacturers of SARS-CoV-2 tests, after scientific advice has been received from the IVD expert pane...
Article 10a MDR/IVDR: provisions apply from 10 January 2025!
The European Commission’s newly released Q&A on Article 10a of the MDR and IVDR (Medical Device Regulation and In Vitro Diagnostic Regulation) i...
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...
Q & A – new Manufacturer Incident Report (MIR) Form
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website....
New documents published by the European Commission!
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sect...
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...
