Europe – Medical devices: Council adopts new measures to help prevent shortages
The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to...
Europe – MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the...
The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to...
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...
Europe – Medical devices AI questionnaire IG-NB & Team NB
This questionnaire is jointly published by the German Notified Bodies Alliance for Medical Devices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IGNB)...
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 – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices...
Medical devices (MDs) and in vitro diagnostic medical devices (IVDs) are essential for a working healthcare system and play a crucial role in the...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
UK – New action to tackle ethnic and other biases in medical devices
Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...
Europe – EUDAMED user guide : Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU
medical devices regulations:
Regulation 2017/745 on medical devices
Regulation 2017/746 on in vitro...
Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic...
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...
