European Council delays application of the Medical Devices Regulation to prioritise COVID-19
The European Council has voted unanimously to delay the implementation of the Medical Devices Regulation (MDR) by one year and … read more »
Guidance published on cybersecurity for medical devices
Ahead of the full implementation of new MedTech Regulations, the European Commission has made guidance available to ensure medical devices … read more »
Slow implementation of MDR and IVDR causing increased likelihood of supply disruptions
Concerns that the MDR and IVDR implementation dates cannot be met are escalating, with only 2 out of 60 notified … read more »
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
Luxembourg and the Netherlands have been included in the GMP mutual recognition agreement between the EU and the US. Both … read more »
EU Expert Group publishes report on tools and methodologies to assess the efficiency of healthcare services
The EU Expert Group on Health Systems Performance Assessment (HSPA) has published its report “Tools and methodologies to assess the … read more »
European Commission and DHSC offer further guidance over medical device authorisation in the event of a ‘no-deal’ Brexit
Both the European Commission and Department of Health and Social Care (DHSC) have sought to offer further guidance over the … read more »
Major update to MAP MedTech’s Europe Section
MAP Europe has been extensively updated to reflect five new detailed guidance documents published in the last few days by … read more »
First IVDR and MDR guidance published by the European Commission
The European Commission has released the first guidance documents for the upcoming In Vitro Diagnostic Regulations (IVDR) and Medical Device … read more »
European Commission considering extending access to Eudamed to non-European authorities
Access to the European Database on Medical Devices (Eudamed) may be extended to non-European regulators in the interests of increasing … read more »
European Guidance on Unique Device Identification (UDI) for medical devices expected in March 2018
On 12 February 2018 a workshop on Unique Device Identification (UDI) organised by the European Commission discussed the principles of … read more »
