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…
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…
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…
Removability and replaceability of portable batteries in medical devices
The EU Battery Regulation 2023/1542 applies to all batteries in the EU, including batteries incorporated into or added to medical devices and IVDs. The Regulation…
UK Regulations on Post-market Surveillance Requirements
On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…