European Commission 2021 Work Programme released
The European Commission (EC) has presented its work programme for 2021, entitled A Union of vitality in a world of … read more »
EC publishes report on orphan medicine regulation
The European Commission (EC) has published its evaluation of the regulations over 2000-2017 (medicines for rare diseases) and 2007-2017 (medicines … read more »
Industry bodies respond to Health Innovation Partnership Proposal
The European Commission is currently considering partnership schemes to take forward under the Horizon Europe programme, among which is the … read more »
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 »
