Canada – Draft guidance on managing applications for medical device ...
Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk. Under...
UK – Medical Devices Regulations: Routes to market and in vitro diagnostic devices
This consultation applies to medical devices in Great Britain. For guidance on the
regulation of devices in Northern Ireland, see Regulation of devices in Northern...
Europe – Pediatricians push for urgent action to stop MDR from disrupting medical device...
The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for...
Europe – Notified body official shares recommendations for successful PMCF plans
Successful postmarket clinical follow-up plans (PMCFs) should be able to provide new information that was not previously known about a device, such as delayed...
USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that...
Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and...
The Communication of the Commission of 11 December 2019 on ‘The European Green Deal’ (the ‘European Green Deal’) is Europe’s growth strategy that aims...
France – PLFSS 2025: le gouvernement veut actionner la clause de sauvegarde sur les...
Le gouvernement a déposé un amendement (au PLFSS 2025 afin- de modifier le montant Z au-delà duquel la clause de sauvegarde "produits et prestations"...
Europe – Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare...
Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires
that the manufacturer shall draw up a summary of safety and performance (SSP)...
