To comply with the EU Medical Devices Regulations (MDR and IVDR), an important deadline is approaching for labels of medical devices and IVDs. From 26…
MDCG update: classification revision of SARS-CoV-2 tests
Today, 18 March 2025, MDCG just released a new version of MDCG 2020-16. This guidance addresses the classification of in vitro diagnostic medical devices under…
Team-NB statement on certificates with conditions
On 12 March 2025, Team-NB released a statement on certificates with conditions. The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR)…
Use of EC REP symbol: ISO standard updated
In March 2025, the International Organization for Standardization (ISO) updated ISO 15223-1:2021 (Amd. 1:2025). This standard describes the the use of symbols for medical devices.…
UK government response to consultation on medical devices regulations: key takeaways for manufacturers
On 26/02/2025, the UK government published its response to the public consultation on proposed amendments to the Medical Devices Regulations 2002 concerning four specific pieces…
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…
IVDR: 14th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Centro Nacional de Certificación de Productos Sanitarios is the 14th EU Notified Body notified…
EMA advice on high-risk medical device clinical development
The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request…
EU clinical investigations and performance evaluations pilot project
In February 2025, the European Commission and Member States have launched a pilot program for coordinated assessments of clinical investigations and performance studies under EU…
Expert panel on classification of COVID-19 tests
The European Commission just published the advice on IVDs testing SARS-CoV-2 issued by the IVDR Expert Panel from the European Medicines Agency (EMA). The document…