Often overlooked, Article II7 of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) lurks within Chapter X of the Final Provisions. However, this article is of high impact to market authorisation holders who provide medicinal products integral with administration devices. Specifically, it states that manufacturers of administrative devices must seek the opinion of a Notified Body regarding the conformity of the device component of the product.
To provide further clarity regarding Article 117, the European Medicines Agency (EMA) has issued guidance on the matter and expects to provide further information on aspects where EMA activities may interact with MDR and the In Vitro Diagnostic Regulation (IVDR) 2017/746.
Although there is much to be sorted with regards to the process of receiving Notified Body feedback of device components, it is likely that they will require the activity code MDS 1001, “Devices incorporating medicinal substances,” while the depth of the assessment and content of the “opinion” provided remains unclear. However, the recent EMA guidance does provides small insight into the process and practical aspects such as circumstances when a new opinion is required. Further information, including the EMA guidance document, may be found here.
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 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.