Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance

Regulatory NewsRegulatory News | 22 August 2019 |  By 

With a new pilot project, the Danish Medicines Agency (DKMA) is looking to aid device startups and small- to medium-sized manufacturers (SMEs) comply with the EU’s Medical Devices Regulation (MDR).

The pilot project will offer guidance on the new regulatory requirements and run from 15 August through the end of 2019, though the regulator will revisit this timeline for a potential continuation.

The agency says it “has experienced increasing demand” from medical device companies for regulatory guidance on the new regulations. “The rules are intended to strengthen patient safety and ensure the availability of new equipment that can benefit patients,” DKMA adds, according to a Google translation of the document. In contrast, many manufacturers, notified bodies (NBs) and authorities alike anticipate the EU device sector being adversely impacted by the transition to the new system over a lack of guidance and implementation delays, among other issues.

By allowing one-on-one meetings with a board, DKMA seeks to make it easier for the companies that the MDR transition is expected hit the hardest. Startups and SMEs also can book one-one-meetings for counseling on the EU’s medical device directives and clinical trial application requirements and processes for specific products and general requirements for CE marking. Yet product approvals, decisions for specific issues and matters in which DKMA can make decisions fall outside of the scope of the guidance under the pilot.

DKMA notes that the one-on-one meetings are to “help and guide well from the start.” But the MDR clock will run out in a little over nine months, regardless of whether manufacturers can comply with the regulation prior to its 26 May 2020 date of application. The stakes are particularly high for small companies.

Startups and SMEs represent 95% of the sector and are looking to bring their products to the US and China, among other regions as alternatives to the EU, MedTech Europe communications lead Jerick Parrone recently told Focus. He argued that “if not resolved urgently and decisively” such “circumstances can profoundly disrupt” the EU’s market and “create a significant ‘cliff-edge.'”



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