Do standalone devices exist? Medical devices are typically used in a wider therapeutic or diagnostic context. They are often used together or sequentially with other products, often medical devices or medicinal products, and sometimes also other types of products. They may be connected or compatible, they may interface or be used simultaneously. They may use … Read more
Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more
Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more
Manufacturer versus importer/distributor The MDR relates specific roles and responsibilities to manufacturers, importers and distributors. Only the manufacturer should therefore make changes to the information provided with the device and the packaging. However, sometimes the importer and/or the distributor make such changes. Article 16 of the MDR/IVDR sets out when such change puts a manufacturer … Read more
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
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