Questions about the European MDR answered The European Medical Device Regulation (MDR) is a revised and new set of regulations from that of MDD that governs the Manufacturing, supply chain, Post Marketing surveillance as major category compliance parameters of medical devices in Europe, and compliance with the regulation is mandatory for medical device businesses that want to even enter their products in the European market. 1. WHY DID THE MDD NEED AN UPDATE? Every regulation always gets updated periodically to include the good and bad part of experience of compliance parameter on users. Finally, these are made for patients and not for business or someone’s earning. This happens with all regulations however, there was massive change needed for MDD after evolution of the world into modern world with Information technology and artificial intelligence being used in many facets of human being and medical device is one of that. When the MDD came as law in 1992, software as a medical device (SaMD) did not yet exist. Software is something that controlled electric machines and making it electronic.There were no apps (Applications- user friendly software for end user’s use) that patients could use to observe their own health. Risk assessment was used very rarely, and risk was not much with very little automation. Most of the measurement or diagnostic tools were used by expert medical professionals and not by patients themselves. Take examples of digital BP measuring device. Sugar measuring device. With introduction of new devices risk profile of the same device changed drastically in many such cases and old MDD if allowed, can cause patient harm rather than support. 2. HOW IS THE NEW MDR STRUCTURED? The new MDR document is 174 pages in length. It contains a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). related with the MDD, which was 60 pages in length, the new regulations are much extended and more detailed. In addition to that, there have been printed 42 implementing acts, which are used to clarify/implement the MDR and 12 delegating acts, used to modify/amend it. Mere dimension of the above description would tell you why new regulation needed. 3. WHAT ARE THE MAJOR THEMATIC CHANGES IN THE MDR? Compared with its predecessor, the MDD, the new European MDR is minus focused on the preapproval stage of medical device manufacturing, and as an alternative, helps a life-cycle (From manufacturing to expiry of device) approach to medical device regulation.
While the old MDD fundamentally served as a manual for how medical device corporations could get their CE marking and get to market, the new regulations encourage policies and measures that raise the responsibilities of medical device companies for their products right from the product development.
4. WHAT DEVICES ARE COVERED UNDER THE MDR? The MDR defines the term "medical device" as an "instrument, apparatus, appliance, software, implant, reagent, material, or other article" that is used for any of the following:   
Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention Investigation, replacement, or modification of an anatomical, physiological, or pathological process Providing data via in-vitro examination of samples derived from a human body
The European MDR is a taste of how the regulatory atmosphere for medical devices will be changing over the next decade. The afresh published ISO 13485:2016 and the MDSAP program are already pushing for better standardization and stronger post-market surveillance necessities, along with process-oriented risk management and a life-cycle approach to device monitoring. Although the effective date for the MDR seems far in the future, compliance today promises to set your medical company up for long-term industry prosperity and unprecedented success in meeting regulatory compliance objectives in valuable markets around the world. Do not count on implementation deadline. It looks big period, but it may be too less time for many those who do not take it seriously. First, understanding an impact on your business is important. This requires an expert advice. If you begin wrongly and spend your resource to arrive at wrong destination, your time is gone, and it may become too late to visualise before your business is already affected. Do you know that what classification you got for your medical device in MDD may not be valid and you need to know and get new classification and then starts your regulation understanding and implementation?