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…
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…
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…
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…
Public Consultation on EU MDR & IVDR is now open
On 12 December 2024, the European Commission launched a feedback period for a targeted evaluation of EU regulations on medical devices and in vitro diagnostics.…