New Medical Devices Regulation and IVD Regulation now publishe
The final text of the new European Medical Devices Regulation (MDR) has been published in the Official Journal of the European Union. The Regulations will enter into force on May 25th, marking the start of the transition period for manufacturers selling medical devices into Europe.
The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
Read the full EU Commission press release here
The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.
The original proposal documents can be found via the following pages.
The final EU Commission text can be found here
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When are the Medical Device Directives changing?
Following entry into force on May 25th, manufacturers have three years to transition to the new Medical Device Regulation. The new rules will apply from May 2020 for medical devices.
Use our Frequently Asked Questions document to learn more about the transition and the changes to the requirements.
Where can I find further information?
This transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.
The official non-BSI websites can also provide additional background and detailed information:
Competent authority, MHRA
If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.