A survey of over 200 regulatory professionals has revealed a lack of understanding of the new Medical Device Regulation (MDR) requirements.
According to the survey, ‘The Race to EU MDR Compliance’, conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS), regulatory affairs and quality leaders at medical device manufacturers need a better understanding of the new rules that govern the ability to sell products in one of the world’s largest markets.
As the 2020 deadline looms, RAPS has announced its latest workshop that examines the impact of the MDR on legacy devices in order to address this need for greater education to ensure compliance.
The KPMG and RAPS survey, titled “The Race to EU MDR Compliance,” found:
- 78% of medical device companies do not have a sufficient understanding of EU MDR
- 58% of all respondents said they had no strategy in place to remediate gaps in their clinical data or processes for collecting data
- When asked about their confidence in being able to meet the regulatory deadline, 45% of North American and 29% of European respondents were “not very confident.”
The European Union updated regulations in 2017 governing medical devices and their accessories, with the aim of improving patient safety by ensuring unsafe or non-compliant equipment stays off the market.
Additionally, the new rules, which come into effect in May 2020, address post-market surveillance, such as data gathering for medical devices on the market. As well as the impacting new devices, legacy devices with valid certifications under the Medical Device Directive (MDD) must also meet the requirements under the new MDR.
The KPMG and RAPS report states that medical device makers should evaluate their products’ clinical evidence right away to see if there are any gaps and develop a remediation plan; address changes that need to be made in the recertification process for existing products; and build cross functional teams from quality assurance, supply chain management and regulatory compliance.
RAPS Executive Director Paul Brooks said: “Preparing for the EU MDR is a major challenge for medical device companies in the European market, with significant implications for both new and legacy devices as it does not grandfather devices that are already CE marked.
“And while there is still a great deal of uncertainty surrounding regulators’ interpretations and expectations, those who are proactive in developing regulatory strategies and contingency plans will very likely find themselves in the strongest position when the 2020 deadline arrives.”
Rajesh Misra, advisory principal in KPMG’s Healthcare & Life Sciences Practice, added: “Medical device makers need to understand that migration to EU MDR will not happen overnight, but a comprehensive plan that brings R&D, regulatory, quality, operations and medical affairs disciplines together will position an organisation on the right path.”
RAPS has now announced the latest in a schedule of workshops that will explore the complex issues of MDR, specific to legacy products. The workshop will take place in Amsterdam, 7-8 November 2018 and brings together representatives of the European Commission, Member State medicinal and medical device authorities, notified bodies and industry experts.