Ask a combination-product team what “the Article 117 consultation” means and most will describe a notified body reviewing a substance incorporated into a device. That is a real MDR procedure — it just is not Article 117. Regulation (EU) 2017/745's Article 117 is an amendment to Annex I of Directive 2001/83/EC, and it governs the opposite scenario: a medicinal product with a device built in, not a device with a medicinal substance built in. Collapsing the two into one “Article 117 opinion” is common shorthand — and it is the kind of imprecision that costs a submission its clock.
Two combinations, two directions
A drug-device combination can be built in either direction, and MDR treats the two directions as genuinely different regulatory events. In one, a medicinal product incorporates a device as an integral part and the combination is placed on the market and authorised as a medicinal product — think a pre-filled pen or an inhaler integral to the drug product. In the other, a device incorporates, as an integral part, a substance that would itself be considered a medicinal product under Directive 2001/83/EC, with an action ancillary to that of the device — the device-under-MDR Article 1(8) scenario. Each direction has its own gatekeeping consultation, and neither is interchangeable with the other.
The ancillary-substance opinion: Annex IX, Section 5.2
When a device incorporates an ancillary medicinal substance, the notified body cannot assess that substance itself. It must seek a scientific opinion — on the substance's quality, its safety, and the benefit-risk of incorporating it into the device — from an authority empowered to evaluate medicinal products. MDR routes that request to one of two places:
- A national competent authority designated under Directive 2001/83/EC, for most ancillary substances.
- EMA, mandatorily, when the substance falls exclusively within the scope of the centralised marketing-authorisation procedure, or when it is derived from human blood or human plasma.
- Analogy to Annex I of Directive 2001/83/EC. The quality and safety verification follows the same dossier logic a standalone medicinal product application would use, scaled to the substance's role in the device.
- A clock that excludes clarification time. The 210-day initial window (60 days for a supplementary consultation on a later change) runs from a complete, valid dossier — time spent answering the authority's follow-up questions does not count against it, which means an incomplete submission can push the real timeline well beyond the headline figure.
Under MDD and AIMDD, the authority's opinion was input the notified body weighed. Under MDR, an unfavorable opinion is a wall: the notified body shall not issue the certificate. The binding-effect change manufacturers still underestimate
Article 117: the other direction
Article 117 runs the consultation the other way. It inserts a requirement into Annex I of Directive 2001/83/EC's marketing-authorisation dossier structure: where the product being authorised is a medicinal product that incorporates a device as an integral part, the application must include the results of the device constituent's conformity assessment against MDR's General Safety and Performance Requirements, in the form of a notified body opinion. A notified body assesses the device side; the marketing-authorisation authority assessing the medicinal product receives that opinion as part of the dossier it is already reviewing. There is no separate ancillary-substance clock here — the device assessment is folded into the marketing-authorisation timeline the sponsor is already running.
- Settle borderline classification first. Confirm the product is a device at all under MDCG 2022-5's mode-of-action test — that question is decided separately and ahead of either consultation.
- Marketed as a medicinal product, device built in? Article 117 applies — a notified body opinion on GSPR conformity goes into the marketing-authorisation dossier.
- Marketed as a device, substance built in? The Annex IX, Section 5.2 ancillary-substance opinion applies — route to the correct authority and budget the 210-day clock.
- Either way, confirm notified body scope. Not every notified body is designated to handle devices with an ancillary substance — verify the code before you submit, not after.
The confusion is understandable — both procedures exist because MDR treats a medicinal substance inside a device, or a device inside a medicinal product, as too consequential to leave to one regulator's expertise alone. But a team that scopes its submission plan around the wrong consultation will discover the gap at the worst possible time: when a notified body says it needs an ancillary-substance opinion the team budgeted as an Article 117 NBOp, or a marketing-authorisation reviewer asks for a device conformity opinion the team never commissioned. Our combination product and EU MDR & IVDR teams scope this at the strategy stage, specifically so the clock gets built into the plan rather than discovered inside it.
Frequently asked questions
Is MDR Article 117 the same as the ancillary medicinal substance consultation?
No. Article 117 amends Annex I of Directive 2001/83/EC and applies when a medicinal product incorporates a device as an integral part and the combination is placed on the market as a medicinal product — the marketing authorisation dossier must include a notified body opinion on the device's conformity with the General Safety and Performance Requirements. The ancillary medicinal substance consultation is the reverse scenario: a device under MDR Article 1(8) that incorporates, as an integral part, a substance which would itself be a medicinal product and whose action is ancillary to the device. That consultation runs under MDR Annex IX, Section 5.2, not Article 117.
How long does the ancillary-substance scientific opinion take?
Annex IX, Section 5.2 gives the consulted authority — a national competent authority or EMA — 210 days from receipt of valid documentation for an initial consultation, and 60 days for a supplementary consultation on a change to the substance. The clock excludes time the manufacturer spends responding to clarification requests, so an incomplete dossier extends the real-world timeline well past the statutory figure.
Can a notified body issue a CE certificate if the scientific opinion is unfavorable?
No. Under MDR, an unfavorable scientific opinion on the ancillary substance's quality, safety, or the benefit-risk of incorporating it into the device blocks the notified body from issuing the certificate. This is a deliberate tightening from the MDD and AIMDD regime, where the opinion was advisory input rather than a binding gate.
Sources & further reading
- Regulation (EU) 2017/745 (MDR), Article 117 and Annex IX, Section 5.2. eur-lex.europa.eu
- European Medicines Agency. Medical devices with an ancillary medicinal substance — consultation procedure and list of substances reviewed. ema.europa.eu
This article is provided for general informational purposes and reflects the regulatory landscape as of October 2026. It is not legal or regulatory advice. Confirm current MDR consultation procedures and applicable timelines with the relevant notified body, competent authority, or qualified counsel before acting.
