Article 117 & Notified Body

Strategic Situation 05

Combination Product Strategy: Article 117 and Notified Body Alignment

Strategic Situation 05

Combination Products · Article 117 · Notified Body · EU Regulatory Strategy

Situation

A company developing an integral drug-device combination product was preparing for EU marketing authorisation. Article 117 device constituent requirements had not been fully integrated into the MAA planning timeline. With Notified Body review estimated at 6–9 months, the NB workstream risked becoming a critical path issue for the submission, with direct implications for filing timeline and programme value.

Contribution

Provided strategic regulatory/MDR advisory on Article 117 requirements, assessed the compliance pathway for the device constituent, and aligned the Notified Body review timeline with the broader MAA submission plan. therainnova AG supports companies with strategic regulatory advisory activities for integral drug device combinations, together with a trusted network of experienced specialists covering Article 117 assessments, device strategy, technical documentation, usability and interactions with Notified Bodies across the EU and Switzerland.

Business consequence

Preserving programme value, reducing regulatory execution risk, and avoiding timeline delays from late-stage device regulatory gaps - protecting the filing schedule and investor confidence.

How we supported the client

To support the client, we performed a gap analysis to identify critical resource gaps. We then closed some of these gaps by leveraging our network. We educated the team on filing requirements, processes, and potential critical steps. We developed a tailored filing plan, filing timetable, and key deliverables. We led the filing team meetings and managed ad-hoc issues on an ongoing basis.

Our support helped the client to successfully submit their MAA. We provided them with the guidance, expertise, and resources they needed to navigate the complex regulatory landscape and achieve their goals.

Strategic
Regulatory
Advice

Interactions with Health Authorities

Submission
Management

Marketing
Authorisation
Application

Client quote

Stephanie @therainnova has been instrumental in guiding us through all aspects of the EU, US and MHRA filing process in her role as interim Head of Regulatory Affairs. She is a highly knowledgeable and experienced senior regulatory affairs leader with a dedication to meet the client`s deadlines and needs.

Dario Eklund

CEO, Santhera Pharmaceuticals

Client quote

therainnova has supported us in our EU MAA submission. Their swift and ad hoc support in preparing tabulated summaries for the EU MAA showcases their unwavering commitment to enable our timely MAA submission. We were very glad and thankful about their ad hoc support.

Omar Lahlou

Director Regulatory Affairs
Allecra Therapeutics

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