The EU Medical Device Regulation (MDR), originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021 due to the impact of Covid-19.
Manufacturer have had the option of re-certifying MDD certifications to buy some time for compliance with the EU MDR. With that said, there has been certification processes required for MDR that are not delayed and need supporting document and product data.
Re-certification under MDD will enable manufacturers to keep their products on the market until May 2024 or the re-certification expiration date, whichever comes sooner. As mentioned above, a re-certification under MDD is dependent on certain circumstances related to the manufactures current MDD standing including the absence of possible gaps in their compliance activities. For example, if not already implemented, a system for risk management, vigilance and post-market surveillance has to be implemented and interlinked as integral parts of the overall quality management.
In the fall of 2019, Medifactia requested a re-certification audit to extend the validity of Medifactia’s Transit-Pellets radiopaque markers EC Certificate. We are happy to announce that Medifactia’s re-certification under the MDD was approved in April 2020.
We have begun the transitioning and plan to make the full MDR transition in 2023.