Preparing for the EU Medical Device Regulation

The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic. (The proposal does need to be approved by EU member states and published in the Official Journal before it will enter into force, but this is expected by May 26, the EU Parliament reports.) The shift from the previous regulations, the Medical Devices Directive (MDD), to the MDR (officially titled Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices), will bring significant changes and a more stringent requirement to obtain the much-needed CE mark. The impact will be felt by every medical device manufacturer in the EU―and those that sell into the EU―because it will apply to existing products, not just new entries to the market. Kolabtree has had many enquiries from medical device manufacturers who need help from a freelance scientist, whether it’s with adjusting to changes to traceability, device classification, or post-market surv...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news