The announcement by the UK Government Department for Business and Trade (DBT) on 1 August 2023, that a broad acceptance of CE marks instead of the UKCA mark for the forseeable future, briefly caused confusion among the medical device community, considering that only weeks before had the transition deadlines for legacy medical devices been extended…
The latest news from the European Commission is that a fully functional EUDAMED is now not likely to be available until late 2026. Originally scheduled to be completed in May 2020, the much delayed roll-out is now taking place in phases, rather than all modules at one time. While some modules are already available, European…
The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, sterilizing products using radiation and using certain materials and alloys. FDA published tables on 1 August listing voluntary consensus standards that are either withdrawn, replaced, corrected or…
The 39th notified body for the medical device regulations 2017/745 and 201/746 (MDR and IVDR) has now been named, this being Health Technology Certification (HTC), located in Nicosia, Cyprus. Details of all currently available notified bodies (29 for MDR and 10 for IVDR) are available on the NANDO MDR and IVDR websites.
MedTech Europe has made a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to compliance with Regulation (EU) 2023/607, allowingmanufacturers to take advantage of the recently announced transition extension timescale for legacy devices. Any manufacturer may freely use the template to make their own declaration, or it may also be completed…
As at the end of March 2023, there have been some further additions to the lists of Notified Bodies now designated under the MDR and IVDR. The latest additions are: MDR: 29 November 2022, Institute for Testing and Certification, Czech Republic 8 December 2022, ICIM, Italy 20 January 2023, SLG Pruf und Zertifizierungs, Germany 20…
A new Commission Implementing Regulation will soon be published to align the implementation timescale for the Common Specification (CS) on MDR Annex XVI products with the revised transition timescales for legacy devices covered in Regulation (EU) 2023/706. The full title of the new regulation as currently drafted is: “Regulation amending Commission Implementing Regulation (EU) 2022/2346…
The US Food and Drug Administration has published a final guidance document titled: ‘General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff’, available from here. The introduction to the guidance states: “This guidance document provides the FDA’s recommendations on animal studies intended to evaluate medical…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its webpage referencing the EU’s publication of Amending Regulation (EU) 2023/607 on the extension of transition times for ‘legacy devices’ under the Medical Device Regulation (MDR, 2017/745) to advise that: “These extensions apply automatically in Northern Ireland. Certificates that have been extended will also…
Further to the acceptance of the European Parliament and Council of the Commission’s recommendations for extending the transition period of MDD ‘legacy devices’ under the MDR, the Commission has published a guidance document titled ‘Extension of the MDR transitional period and removal of the ‘sell off’ periods: Q&A on practical aspects related to the implementation…
