Person Responsible for Regulatory Compliance Article 15 of both MDR and IVDR require manufacturers and authorized representatives to appoint a Person Responsible for Regulatory Compliance (PRRC). MDCG Guidance 2019-7 provides guidance (be aware that this guidance is under review and we may see a new version in Q4 of 2022). Appointing the right person for … Read more
A government response to a public consultation On 26 June 2022 the MHRA published the Government response to consultation on the future regulation of medical devices in the United Kingdom. This document provides evidence of how the UK government wants to develop legislation in the future and how this is communicated with stakeholders. For medical … Read more
Instead of guidance: position paper MDCG 2022-11 is presented as a position paper of the MDCG about how manufacturers of medical devices may approach the MDR certification bottleneck around May 2024. Personally I think this is one of the best guidance documents the MDCG has produced so far, because it tells industry very well what … Read more
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) The Medical Devices Regulation (EU) 2017/745 (MDR) put extra emphases on PMS and PMCF. It basically requires the manufacturer to keep establishing compliance as real life data is actively collected during the lifecycle of the device, as appropriate for each phase of the lifecycle. Medical devices are … Read more
UKCA marking for different product categories Now the UK has left the EU, the timelines for accepting CE marking on the Great Britain market are coming to an end. All CE marked products must be UKCA marked by 1 January 2023, except for medical devices and IVD’s which must be UKCA marked by 1 July … Read more
UKCA-marking and devices Medical devices and IVD’s (devices) that are placed on the UK market can still be CE-marked, but the UKCA-marking is also possible. For these devices the UK Medical Devices Regulations 2002 apply, which is basically the UK version of the ‘old’ combined directives (AIMDD, MDD and IVDD). Although the Regulations 2002 have … Read more
The justification of the status of a medical device or IVD and their risk class is where you make the first impression Annex VII, Requirements to be met by notified bodies, describes among other things, how a notified body will review applications for certification (Annex VII, section 4.3). These are the first hurdle a company … Read more
IVD’s moving between EU and Switzerland or vice versa On 26 May of this year the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will become applicable. From that date the status of devices involved will change, although they remain physically identical. That means for example that IVD’s can no longer move on the Single … Read more