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…
Donawa Lifescience President, Maria E. Donawa M.D., spoke at the 2nd Conference on Clinical Studies with Medical Devices and IVDs, which took place in Vienna, Austria, on 30-31 March 2023. This year’s conference was designed to provide a wealth of information for both medical device and in vitro diagnostic clinical investigations, with a particular focus…
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…
Following last week’s formal approval of the European Commission’s proposal to extend the transition timelines for certain ‘legacy devices’ and eliminate the ‘sell-off period’ from the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), Amending Regulation (EU) 2023/607 has now been published. The Preamble to the Regulation states, as industry…
In the UK Chancellor of the Exchequer’s budget statement on Wednesday 15 Marcy 2023, the potential future of medical device regulation was included. Based on an interim report from Sir Patrick Vallance, UK Government Chief Scientific Adviser, dated 8 March 2023, the Chancellor announced a commitment to some of the early outcomes of the ‘Regulatory…
Commission Delegated Regulation (EU) 2023/502 of 1 December 2022, which took on 11 March 2023, reduces the frequency of complete re-assessments of notified bodies from three years (1st complete re-assessment) and four years (following the 1st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment…
