Thank you for a very helpfull piece of advise, when you suggested that I should write a rationale for me being appointed as PRRC in my company. Only a few days later, the auditor asked for it during our Tech File Assessment before (hopefully) achieving our MDR CE certificate.
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
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
Ronald has unique ways of approaching a problem. He always looks at it from multiple perspectives and is great at seeing what could be lurking around the corner, or which may have been put in a closet out of sight. Personally I like to discuss complex borderline and classification issues with him and he is … 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
Any company can suddenly be hit by a complex and high risk case. In such situations it is necessary to get a good understanding of the underlying problem and of the expectations by the authorities and notified body, and also to ensure proper communication with all stakeholders, including the press. Leaning on in person experience … Read more
Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation and consulting), so he can approach most challenges from mulitple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over … 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
Boumans Regulatory Consulting BV
