On 5 May 2025, the European Commission released an updated version of the Manufacturer Incident Report (MIR) form (version 7.3.1). This version will become mandatory…
IVDR: 17th Notified Body on NANDO!
Since the 1st of May 2025, the NANDO database has a new Notified Body under the IVDR! DNV Product Assurance from Norway is the 17th EU…
IVDR: 16th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! SGS Belgium is the 16th EU Notified Body notified under the Regulation (EU) 2017/746…
National analysis of MDR & IVDR: Romania
The Romanian implementation laws of the MDR (Emergency Ordinance no. 46 of 9 June 2021) and of IVDR (Emergency Ordinance no 137 of 12 October…
2025 deadlines for medtech in the EU, UK, and Switzerland
2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…
Initiatives to reform MDR and IVDR
Since the Medical Devices Regulation (MDR) and the In-vitro Medical Device Regulation (IVDR) came into full force, several individuals and associations have raised concerns regarding…
New Product Liability Directive (PLD): What is changing?
On 18 November 2024, Directive (EU) 2024/2853 on liability for defective products (new PLD) was published in the Official Journal of the EU. The new…
Transitional provisions for Class D IVDs: Updates to MDCG 2021-4
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
IVDR: 13th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…