EFPIA Blog to request delay of application of Article 117 to marketed combination products

Pragmatic Solutions Needed for Lifecycle Management of Drug-Device Combinations

May 26, 2021 is the fast approaching date of application of the Medical Devices Regulation (MDR) and with it, the requirement for Industry to ensure compliance with Article 117 for integral device components of a medicinal product.

Pfizer’s @amanda.matthews posted a guest blog on the EFPIA website about a letter sent to the Commission requesting delay to the requirements for a Notified Body Opinion (NBOp) for substantial changes to currently marketed products, raising awareness that there is insufficient clarity about how this process will work.

When Amanda shared the blog on LinkedIn, it received over 3,000 views, demonstrating the intense interest in this topic.

The recording of the EMA Webinar on Combination Products and application of Article 117 is available now. It clearly highlighted the different philosophies to lifecycle management between the pharma and device worlds.
Webinar link

The EFPIA suggestion is to delay application of Article 117 to currently marketed products until the variation regulatory framework (EC 1234/2008, 24th November 2008) has been revised - as described in the recently published EU Pharmaceutical Strategy.
EFPIA blog.

TEAM NB recently collaborated across their member notified bodies to issue detailed flowchart guidance on how they would review device related changes under Article 117 to decide if they were substantial and needed a new NBOp.
TEAM NB position paper

This could be a useful basis for agreement across medicines and medical device competent authorities, EMA and the Commission. At the EMA webinar, it was shared that a new Task Force has been set up to address the challenges, with the aim to finalise guidance on Article 117 prior to the full implementation date of the MDR, May 26, 2021.

Thanks to everyone involved in trying to bring clarity to the development, regulation and lifecycle management of drug-device combination products!

Looking forward to seeing the final guidance soon as a positive collaboration across EMA, national competent authorities, drug and device DGs of the Commission and notified bodies :wink: