Many companies are still struggling to understand and act on the new European Union Medical Device Regulation123 articles and 17 annexes
With the 2020 deadline fast approaching for complying with the new European Union Medical Device Regulation (EU MDR), 78% of regulatory and quality leaders at major medical device companies in Europe and North America lack sufficient understanding of the rules to effectively comply, according to a survey of 220 professionals conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS).
The updated regulations focus on product evaluation, with stringent procedures intended to ensure safety of medical devices. Although the compliance deadline was established when the EU MDR was passed in 2017, many companies are still struggling to understand and act on its 123 articles and 17 annexes—a struggle they identified as the greatest barrier to compliance. In addition:
Despite these concerns, medical device makers that work smart will be able to prepare appropriately for EU MDR compliance. A critical step is to approach the effort as a business transformation opportunity, rather than merely a regulatory obligation – one that can enable the organization to transform its processes, products, systems, and structures to drive sustainable business value. Establishing cross-functional teams that include quality assurance, supply chain management, and regulatory compliance will help ensure understanding of the regulation’s dependencies and impacts across functions and drive support for the effort across the organization.
Migration to EU MDR is a complex undertaking, but a comprehensive plan that brings R&D, regulatory, quality, operations and medical affairs disciplines together will put an organization on the right path.