Porta Medica, in cooperation with the Czech Agency for Standardization, published in 2022 both a book (printed) and an electronic version of the first Czech commentary on the Medical Device Regulation (EU) 2017/745 (MDR). However, this year saw the release of a fairly substantial amending Regulation (EU) 2023/607, which significantly changes the rules of the game for the period 2024 to 2028.
Many manufacturers and distributors of medical devices, as well as healthcare providers, are now finding it difficult to navigate the conditions and requirements that need to be met that so-called legacy devices, i.e. devices that have been assessed for compliance under the previous MDD and AIMDD, can continue to be placed on the market and distributed. At the same time, new MDCG documents are published basically every month, which serve to unify interpretation and practice in the implementation of MDR. And it is with all of the above in mind that Porta Medica is preparing to release an updated MDR commentary, this time in English as an eBook, with global distribution. The publication is expected to be released for sale later this autumn. So if you have a basic knowledge of regulatory terminology in English, you have something to look forward to.
At the same time, more and more hospitals, laboratories, manufacturers, importers and distributors of IVDs are contacting us with the request to prepare an expert commentary or rather a guide to the regulatory changes brought by IVDR. After a short search, we confirmed that at the pan-European level, an order of magnitude more space is given to MDRs and general medical devices, although a much bigger revolution is taking place in the IVD field, where there are also more interpretative and application question marks. For these reasons, we have already started work on the preparation of a practical guide to IVDR in English, which should be published again as an eBook within the next year. English was chosen for both this year's updated MDR commentary and the forthcoming new IVDR commentary due to the size of the domestic and international demand, as well as the fact that most manufacturers are now producing IVD technical and system documentation in English so that these can successfully pass the certification process with foreign notified bodies.
Author: Jakub Král