The reality in today’s global market is that any medical device producer needs to be aware of what is potentially a plethora of regulations for their intended market(s). Organisations are naturally well-versed in the different device classifications used in the US and the EU but are having to come to terms with the fact that the changes in world regulation means a strategy is required for any organisation wishing to sell their product globally.
There are many compliance considerations but key for many are the MDR regulations… whether you’re EU-based or not, if you wish to sell in the EU you need an EU licenced device and you need to maintain that licence with annual records to demonstrate the efficacy and safety of your product. It’s not just Europe, legislation that tightens regulatory requirements is being brought in across the globe, for example IMDR in India.
Additional impacts of regulatory changes and additions from MDR:
26 May 2021, is the date of application (DoA) for the European Union’s Medical Device Regulation ((EU)2017/745) –“MDR”. The introduction to the legislation states:
(4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.
Devices already on the market under the Directives 90/385/EEC and 93/42/EEC – and those expected to have completed the compliance process before 26 May 2021 can continue to be made available (or enter the market) until May 26, 2024 providing:
Whether pre-licence or post-market it’s important to have a thorough understanding of the MDR regulations and their global impact. Our info sheets and articles are a useful starting point, if you want further details.
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