As we move into the second quarter of 2026, the regulatory landscape for In Vitro Diagnostics (IVD) in the European Union is reaching a critica...
Breakthrough medical devices: information session
In December 2025 the Medical Device Coordination Group (MDCG) published a guidance introducing the EU Breakthrough Devices framework, supportin...
Annex IX 2.4 – A logical approach
When does a change become “substantial” under the MDR/IVDR—and when must your Notified Body be informed? MDSS is seeing a rising number of quest...
New EU Packaging Regulation (PPWR) – briefly explained
With Regulation (EU) 2025/40 (PPWR), the EU introduces new rules for packaging. This also affects medical devices and in vitro diagnostic devic...
Goodbye DMIDS, Hello EUDAMED!
Germany switches fully to EUDAMED The German authority BfArM has announced that EUDAMED will replace all national device notifications in Germa...
Newsflash – Recently Harmonized Standards
Recently, twelve standards were added to the list of harmonized standards under the EU MDR (Regulation (EU) 2017/745). The list of standards, p...
UK MHRA Proposes Indefinite Recognition for CE-Marked Devices
The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a...
EUDAMED user guide – UDI Devices
The European Commission has published a new EUDAMED User Guide – UDI Devices (Production v2.22.0 – 2026), providing comprehensive and...
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...
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...
