The EU Commission has released draft documents correcting aspects of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These drafts are currently under review by the EU Competent Authorities with comments expected by 20 March 2019. You may locate these documents by clicking on the links below:
Unfortunately, the opportunity to provide substantial clarifications has been missed, with changes primarily limited to typographical amendments for both guidance documents (English language changes may be found on page 38 of the MDR document).
Specific to the MDR document, the most notable changes are the amendments to the requirements placed upon Notified Bodies (NBs) in the area of technical document sampling in Annex VII and Annex IX. These modifications could potentially impact the number of products reviewed by an NB during the period of certificate validity.
As these are draft documents, it is possible the final version may differ after input from the Competent Authorities of the EU Member States. NAMSA will continue to keep clients abreast of the situation.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.
Additionally, NAMSA provides support to market authorization holders, including training on MDR requirements, MDR/IVDR conformity strategies and compilation of appropriate technical documentation for submission to Notified Bodies.
If you would like to discuss the impact of these recent EU regulatory changes, please get in touch with us by visiting https://www.namsa.com/contact-us/ or by calling us directly at +1-419-666-9455.
We also welcome you to access NAMSA’s many MDR/IVDR planning resources here: https://www.namsa.com/mdr-ivdr-resources/.
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.