Yearly Archives: 2021

MDCG guidance on administrative practices and technical alternatives until EUDAMED full func­tionality

The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional. The document seeks to provide clarification in a highly ambiguous scenario. Nu­merous references in Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are related to EUDAMED and new and comprehensive registration procedures.

Regulatory requirements for placing medical devices on the UK market

OVERVIEW

From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices and IVDs will change.

Manufacturers wishing to place a device on the UK market will first need to register with the MHRA.

Where a manufacturer is not established in the UK, in most cases it will need to designate a UK Responsible Person to register and act on its behalf.

Manufacturers will need to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs.

New Medical Device Regulations in Thailand

On February 15th the Thai FDA published significant new guidance governing the classification, common submission dossier template requirements, fee schedule and transition plan for medical device registration. This action enhances the harmonization of Thailand’s Medical Device Act B.E. 2562 (2019) (Issue 2) and the ASEAN Medical Devices Directive. The guidance is effective immediately for all new registrations and means a substantially increased regulatory burden for the vast majority of medical devices.