Euro Convergence: Experts advise on ways to manage the MDR grace period

Regulatory NewsRegulatory News | 10 May 2021 |  By 

Elizabeth Gfoeller, MED-EL

Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.
At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.
The EU Medical Device Regulations (MDR) is a new set of new regulatory requirements covering the distribution of medical devices in Europe; compliance will be mandatory for companies wanting to sell their products in the EU. MDR comes into effect 26 May 2021, after a one-year delay related to the public health emergency of the COVID-19 pandemic.

Together with the parallel In Vitro Diagnostics Regulations (IVDR), MDR will replace the Active Implantable Medical Devices Directive (AIMD), the In Vitro Diagnostics Directive (IVD Directive) and the Medical Devices Directive (MDD). The IVDR is currently nearing the end of a 5-year transition period and will become fully effective on 26 May 2022.
In November 2019, the European Commission issued a second corrigendum to the EU’s MDR grace period for compliance, allowing manufacturers of certain Class I medical devices an additional four years, to 26 May 2024, to comply with the regulation. (RELATED: Second MDR corrigendum targets class I devices, Regulatory Focus 26 November 2019)
Start planning now
Elizabeth Gfoeller, the corporate director of regulatory affairs for MED-EL, a EU medical device manufacturer based in Innsbruck Austria, said the company figured early that transitioning  their products over to MDR would  take a lot of work, so MDR planning for MED-EL started five years ago, in 2016. The company manufactures hearing loss devices and other products as well. Their products fall under the scope of the IVD Directive, the MDD Directive, and the AIMD Directive.
 “Being in Europe, we had to make sure that we came to terms with this reality…we wanted to hit the ground running,” Said Gfoeller. By the summer of 2019, her company had applied for MDR certification, and was certified as being MDR compliant by March 2020.
“We are at the starting point,” said Gfoeller.“In March 2020 COVID took over our lives but luckily we had the audit before COVID hit.”
Gfoeller said, “We will get there. But the next three years will be like learning to drive, where we will have to learn our blind spots.”
Keep communicating with notified bodies
Martin Witte, the senior director of strategic business development for the notified body TÜV SÜD’s product services division in Munich, Germany, had another tip. It is important for medical device manufacturers to keep in close contact with their notified bodies and keep them apprised of their business continuity plans to ensure their devices continue to circulate on the market after MDR is fully in effect, he said
“You must keep in communication with your notified body. If you are placing your product on the market in November 2023, the best thing is to plan these projects with your notified body……you don’t want to plan them at the end of 2022,” Witte warned.
No grandfathering allowed
Erik Vollebregt, a partner with the firm Medical Device Legal in Europe, said it is important for manufacturers to ensure that their products are MDR-compliant early on because there will be no grandfathering of legacy products to the MDR.
He said that “there is no grandfathering in the MDR. There are still companies that do not understand that sooner or later your device needs to relate to the MDR in one way or another.”
RAPS Euro Convergence 2021


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