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 twelve months from July 2023 to July 2024.
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 of a notified body, which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.
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 start using the UKCA marking for products placed on the Great Britain market, extending the deadline to 1 January 2023.
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 who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).
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 fully comply to the new provisions unless a valid CE certificate issued under IVD Directive (IVDD) is available. The latter scenario will be applicable only…
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 a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied…
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 Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the…