On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: To extend the current standstill period by…
The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics (EU) 2017/746 (IVDR) for products that still need assessment…
The UK Government has announced an extension to the acceptance of CE marking in the UK until 1 January 2023. This means the businesses will have a further year to…
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers…
GMED SAS, which is based in France, has been assigned as the sixth notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR),
The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to…
The Medical Device Coordination Group (MDCG) has issued a guidance document MDCG 2021-7 for manufactur¬ers of in vitro diagnostic medical devices that relate to SARS-CoV-2.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance giving details impor¬tant for companies registering devices on the UK market.
The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not yet functional. The sponsor of…
Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system. UDI is an international system for identifying…
Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) on May 26,…
The date of application of Regulation (EU) 2017/745 on medical devices is approaching and the European Commission has issued new and updated guidance documents. Please find below a list of…
Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro…
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…
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…
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…