Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
South Korea – South Korea rules on emergency production and distribution of medical products
Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE).
The Ministry...
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...
France – Arrêté du 22 février 2023 portant approbation du référentiel d’interopérabilité et de...
Le ministre de la santé et de la prévention,
Vu le règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif...
Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
Le paysage réglementaire mondial continue d'évoluer rapidement en matière de medtech ; de nouvelles exigences sont mises en place et le nombre de marchés...
USA – FDA revises magnetic resonance guidance to reflect updated international standard
The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One...
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
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)...
USA – FDA considers pilot for lower radiation levels for device sterilization
The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency...
UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
