Guidance for EU MDR (Medical Device Regulations) Implementation | HCL Whitepaper

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European Council has released “Medical Device Regulation 2017/745” on 25-May-2017 in place of Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/385/EEC. Adoption of medical device regulation is the strategic decision of the manufacturer. The MDR is more comprehensive and well detailed in comparison with the previous directives and some of the requirements are quite rigorous as well. Compliance to MDR is expected to take considerable cost, effort and time. However, understanding the requirements better will definitely help implementing the changes quicker, reducing the cost associated and the time to market. This White Paper focuses on implementation guidance for the following topics such as timeline duration for MDR compliance, Reclassification of medical devices, Updates in the technical documentation, Post market surveillance and vigilance and Conformity assessment. MDR is expected to bring significant changes that will have an impact on all medical devices currently in the EU market. Though the initial transition may seem to consume considerable efforts, Manufacturers adhering to MDR can taste the success downstream in the immediate term (early bird adoption benefits & associated market share) and in the long run (robust process for product development, realization and PMS).