The EU Commission’s website dedicated to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning has recently been updated, and now includes a new and dedicated page for preparation of the new regulations. This online resource, found here, includes a tool for stakeholders and Economic Operators to search for information specific to their product type and organizational role, among other search criteria.
Under each of these sections (shown below) are key resources as well as other “related resources;” these include a list of the most recent, relevant documents from the EU Commission Document Library and related websites. The additional websites referenced contain links to documents of various ages and provenance.
Although it may appear at first glance that there is no new information within this online tool, the creation of dedicated pages to MDR/IVDR planning supports the goals of the EU Commission, which is to better communicate with stakeholders and to provide a more convenient go-to resource for EU manufacturers planning for the quickly approaching MDR/IVDR dates of application.
NAMSA recommends that EU manufacturers thoroughly review relevant pages for their particular sectors to stay abreast of developments. This is now more critical than ever as we have passed the halfway point of the MDR transition period (26 May 2020)—just 16 months away!
How can NAMSA Help?
Navigating the international regulatory landscape can be overwhelming for any medical device manufacturer. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements and market success.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. In fact, our internal teams are partially comprised of experts from five leading Notified Bodies, putting this knowledge to work for you–ultimately providing more accelerated and cost-efficient regulatory outcomes to clients.
If you are interested in speaking with us about EU-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.