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…
Have your say on electronic IFUs for medical devices
On 21 February 2025, the European Commission published a public consultation on electronic instructions for use (eIFUs) for medical devices. The consultation is open from…
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…
New MHRA guidance on classification of DMHTs as software medical devices
On 3 February 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a new guidance document to help manufacturers navigate the regulatory landscape…