CEO’s and General Managers: selecting a PRRC is not a popularity contest

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

Erik Vollebregt of Axon Lawyers, Amsterdam

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

When is UKCA marking necessary?

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

Emergency assistance

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

About Ronald Boumans

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

Justification of product status and risk class

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