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Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

Adrian Keene

Regulatory NewsRegulatory News
Posted 28 October 2020 | By Nick Paul Taylor 

Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

2977 Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.
The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creating considerable uncertainty about what is expected of manufacturers. MDR, which uses the term PMS 66 times, is intended to reduce uncertainty but is creating new challenges in the process. 
“There's going to be a lot more effort required,” said Adrian Keene, director of EMEA consulting services at NAMSA, a private firm. “We know that the claims for legacy devices all need to be supported, so we're going to utilize the article 120 grace period and try and find pragmatic – and I think it's very important they are pragmatic – PMCF approaches to gather relevant data.”

Daniela Karrer, vice president of operations and clinical affairs at Donawa Lifescience, shared a closer look at the approaches available to companies. In some cases, companies may need to run randomized clinical trials, the highest level of evidence in the MDR hierarchy. However, the cost and complexity of such trials means companies may want to find other ways to generate evidence to support their devices. Manufacturers of legacy devices may be able use existing data.
“[These] data [exist] somewhere hidden in medical records,” Karrer said. “They are really relevant, and interest is justified. However, please keep in mind that informed consent for use of these data is, in most cases, required.”
In some cases, a hospital will have obtained informed consent at the time the subject was treated, facilitating the use of the data in research. If that is not the case, a manufacturer would need to call all the patients to get their consent.
Karrer said manufacturers that have informed consent need to consider whether all the data they need have been collected. Hospitals collect data as part of the standard of care, potentially leading them to fail to gather some information that is important to manufacturers. “You will inevitably find gaps,” Karrer said. 
Other sources of evidence available to manufacturers include investigator-initiated studies (IIS) and surveys. Both sources have weaknesses. Karrer said regulatory compliance is often an issue with IIS, contributing to questions about data quality, whereas bias is a problem with surveys. Even so, in some situations the sources may prove useful. Companies should plan gather evidence soon, no matter how they plan to do it.
“Your window of opportunity is between now and when your certificate is going to expire and when you're going to submit to the notified body to fill gaps in sufficient clinical evidence. You still have time, but there's not so much time left to fill those gaps,” Keene said.
The timing of some requirements remains uncertain. Keene said elements of MDR imply that PMCF plans should be submitted at the full date of application, which is now 26 May 2021. However, PMCF plans are predicated on having understood the clinical benefit and met the increased expectations of MDR.
“It's hard to judge how you could have a PMCF plan without having addressed those pieces of the MDR requirements,” Keene said. “We don't yet know how notified bodies are going to interpret that. It's one of the things that I would recommend having a discussion [about] with your notified body to clarify their expectations.”
Keene added that the purpose of the transition period is to allow manufacturers to move to the new regulatory regime “in a reasonable manner.” A document released by the Medical Device Coordination Group refers to the possibility of gathering clinical data via PMCF to prepare for MDR but, as Keene sees it, “there's uncertainty that still needs to be resolved.” 
Euro Convergence 2020


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Tags: data, EU, MDR

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