I’d like to thank members for sending me questions and concerns relating to IVD regulations. This has spanned a wider remit than I initially expected it to, but the key topics that seem to be coming up time and time again are the concerns with MHRA registrations (which Doris-Ann spoke about in last week’s newsletter), and the transitional concerns relating to the new UK regulations.
The tight timelines are something BIVDA will include in our response to the MHRA consultation, and flag to MHRA generally that this is making it difficult for members to comply with the requirements.
Another topic that has come up are the requirements around economic operators. The MDCG published guidance in August which clarifies the processes for certification of economic operators where they are taking on the obligations of a manufacturer (Article 16 of the IVDR). As well as this, a Q&A document was published in October on this same topic. Under the IVDR there will be tighter requirements and expectations on economic operators, and it’s important to know what this means for your organisation. I would encourage you to have an open dialogue (if you haven’t already) with those in your supply chain so that everyone is on the same page with their expectations.
Please continue to send in any queries and we will be happy to help our members on both an individual and collective basis as issues arise.