Under EU MDR Article 117, manufacturers of medicinal products with integral device components (like pre-filled pens, syringes, inhalers) must submit a Notified Body Opinion (NBOp) as part of their Marketing Authorisation Application (MAA) — unless the device part already carries a CE mark.
Nearly 25% of medicines registered with the European Medicines Agency (EMA) include a medical device component. That means one in four new medicines may trigger Article 117 obligations — impacting product timelines, regulatory strategy, and launch readiness.
A Notified Body (NB) is tasked with independently confirming whether the device component complies with the General Safety and Performance Requirements (GSPRs) listed in Annex I of the MDR.
Who needs an NBOp?
Marketing Authorisation Holder (MAH) or MAA applicant can request an NBOp. Device manufacturers can provide technical documentation, but they cannot apply for the NBOp themselves
10 Things to get right in your article 117 submission:
Confirm applicability
Is your product a single, integral combination of drug and device? If so, and the device is not CE-marked, an NBOp is required.
Plan for at least 6 months
Most notified bodies declare minimum NBOp timelines of 6 months, often longer — especially with multiple review rounds and clock stops.
Support your submission with a clear summary
A cover letter isn’t always mandatory, but a well-structured summary helps the NB quickly grasp scope, changes, and relevance — especially for variations or extensions.
Structure your technical documentation smartly
For example follow MDR annex ii format, use bookmarks and hyperlinks, and ensure logical flow. Poor organisation causes costly delays.
Provide a GSPR checklist with justifications
List applicable requirements, explain exclusions, and link to specific evidence (test reports, certificates, validations).
Human Factors must be demonstrated
For products used by patients or caregivers, you must provide usability engineering data. Follow EN 62366-1 or other HF guidelines and validate critical tasks with representative users, and link to risk controls and IFU.
Robust Risk Management is essential
Your documentation should follow EN ISO 14971, covering design, manufacturing, usability, and post-market phases. Clearly define risk acceptability criteria and show lifecycle integration.
Sterility & Biocompatibility require validation, not Just claims
Include sterilisation validation protocols (OQ/PQ), subcontractor certificates, and risk controls.
Biocompatibility data should follow EN ISO 10993 series, address CMR/ED substances, cumulative exposure, and toxicological risk assessment.
Translations must be accurate and complete
Poor translation of IFU, labels, or user materials leads to avoidable rework. Submit high-quality versions aligned with MDR language rules.
There is no fast track
Notified Bodies do not offer expedited NBOp reviews. The only way to speed up the process is by submitting complete, well-organised, high-quality documentation from the start.
If your team needs support preparing for Article 117, validating technical documentation, or aligning your device component with MDR requirements let’s get in touch with BMCT. We’re here to help you navigate the process with clarity and confidence.
Related articles:
ISO 20069 – A Guide to Assessing Changes in Drug Delivery Systems – BMCT