The Count- down has started for EUROPEAN UNION Medical Devices Regulation ( MDR) – Decode the Key Factors to be Considered as per EU MDR
The Count- down has started for EUROPEAN UNION Medical Devices Regulation ( MDR) – Decode the Key Factors to be Considered as per EU MDR
With in just six months before the EU Medical Devices Regulation (MDR) will be implemented as a mandate, Medical Device manufacturers must begin planning and preparing for the major changes ahead, or risk having their products withdrawn from the EU market.
The EU MDR (Medical Devices Regulation) is expected to establish a stable, transparent, safe monitoring in close observation and secure Regulatory system for the supply of medical devices as a necessary response to technological and scientific advances that are rapidly shaping the medical device industry in the EU region. With the EU MDR transitional phase coming to an end on May 26, 2020, Medical Device manufacturers must consider the following main factors:
Medical Devices Manufactured until May 2020 can comply with MDD Regulatory standards as per regulations applicable at that period or update as per new EU MDR Regulations. However, after May 2020, they will be required to update their current CE licenses, and all new devices will be required to comply with the new MDR.
Defining necessary methods and process for the regulatory transition’s.
Creating a post-market surveillance (PMS) strategy to monitor the products’ safety profile.
Conducting a gap analysis between the current MDD and the proposed MDR/IVDR in order to resolve regulatory concerns in a timely manner.
Along with the other technical papers, submit a QMS (quality management system) report for compliance evaluation by Notified Bodies.
With the transitional phase coming to an end, manufacturers must take the above-mentioned factors into account without fail in order to achieve EU MDR compliance. We believe that now is the time to plan and be ready. By collaborating with the best in the industry, you will gain a comprehensive understanding of the EU MDR. Keep your products complaint.
CATEGORY: Medical Devices, Regulatory Affairs
Keywords: EU MDR, EU IVDR, Regulatory Affairs, Medical Devices, MEDICAL DEVICE REGISTRATION, EU MDR FILING, Medical Devices Regulation (MDR), MDD, INVITRO DIAGNOSTIC REGULATION (IVDR), MEDICAL DEVICE Post Marketing Surveillance (PMS).
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