MedTech Europe is asking the European Commission and EU member states to release guidance clarifying that notified bodies may conduct audits virtually in place of on-site audits during the pandemic for new devices and in-vitro diagnostics. The group stressed in a new position paper that going forward the scope of the virtual audits should not…
The European Medical Devices Coordination Group (MDCG) has just published a new guidance document titled ‘Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal…
The NANDO website for the In Vitro Diagnostics Regulation (IVDR, 2017/746) has at long last reported an increase in the number of notified bodies designated to act under this regulation, from three to four. The latest addition is TÜV SÜD Product Service GmbH Zertifizierstellen, Germany, notified body reference number 0123. Although the date of application…
The European Commission website page devoted to EUDAMED has now been updated to provide information on when the first modules of the system needed to support the new device regulations will be available for the various actors to use on a voluntary basis. The webpage explains that: The development and implementation of EUDAMED is a…
The pan-European industry association MedTech Europe has published four documents in recent days to assist device manufacturers navigate the coronavirus pandemic and the transition to compliance with the new regulations (MDR, 2017/745 and IVDR, 2017/746). The statement relates to the potential for clinical investigations, including post-market clinical follow-up (PMCF) studies needed for recertification purposes, to…
On 18 May 2020, the European Commission published in the Official Journal of the European Communities ‘Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies’. The 920/2013 regulation detailed “a common interpretation of the main elements of the criteria for…
The European Commission has now published the standardisation mandate for the harmonisation of standards under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) in the European Standards section of the Commission website. The mandate is titled: ‘M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the…
On the 26th May 2020, DIMDI and the Federal Institute for Drugs and Medical Devices (BfArM) will join to become one agency, “to better prepare for the future”, according to the German Federal Minister for Health. Once DIMDI is merged into BfArM, the DIMDI name will no longer be used after 50 years of operation….
The European Commission has published two new guidance documents on its website in addition to making available an up-to-date consolidated version of the Medical Device Regulation (MDR, 2017/745). The new guidance documents are: MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745, and Communication from the Commission: Guidelines on…
Intertek Medical Notified Body AB has become the 14th Notified Body to be designated under the Medical Device Regulation (MDR, 2017/745) and the first from Sweden. Intertek Sweden has NB reference number 2862, according to the NANDO website. No further NBs have been added to the NANDO list for the In Vitro Diagnostics Regulation (IVDR,…
