If you’re developing an autoinjector, a prefilled pen or an inhaler, most of the regulatory attention (and usually most of the budget) goes on the drug. The device tends to get treated as packaging until fairly late in the programme, and that’s exactly where Article 117 catches people out. It’s the part of the EU Medical Device Regulation that pulls the device into the medicines submission, and it has quite a bit to say about how you should run the device development from the start, so I thought it was worth a plain explanation written for developers.
What Article 117 actually is
Article 117 doesn’t sit in the device rulebook at all, which is partly why it gets missed. It’s an amendment the MDR made to the medicines legislation (Annex I of Directive 2001/83/EC), and it applies to single integral combination products. That means the drug and the device form one product, it’s intended to be used only in that combination, it isn’t reusable, and the medicinal part does the main job. A prefilled syringe is the classic example, and autoinjectors, prefilled pens, prefilled nebulisers and inhalers supplied with the drug already in them all sit in the same bucket.
Products like that are regulated as medicines, so they reach the market through a marketing authorisation rather than through CE marking as a device. The device constituent still has to be shown to meet the device requirements though, and Article 117 is the mechanism that makes that happen.
Co-packaged products are different. If the syringe is supplied in the box alongside a vial, that syringe is a medical device in its own right and needs its own CE marking, with a proper technical file behind it. If that’s your situation, our guide to what actually goes in a technical file is probably the more useful read.
What the marketing authorisation application has to include
The wording Article 117 added to the medicines legislation says the marketing authorisation application must include evidence that the device part conforms with the relevant general safety and performance requirements (the GSPRs) of Annex I of the MDR. There are two ways to provide it. If the device is already CE marked, or the manufacturer holds an EU declaration of conformity for it, you include the results of that conformity assessment. If not, and the device would need a notified body if it were sold on its own, the applicant has to provide an opinion from a notified body (usually called an NBOp) on the conformity of the device part with the relevant GSPRs.
The only carve-out is a device that would be Class I and self-certifiable if used separately, meaning non-sterile with no measuring function. Most integral delivery devices are sterile, measure a dose, or both, so realistically, if you’re building one of these products, you should plan on a notified body opinion being part of the submission.
What the notified body actually looks at
This is the bit I’d want every development team to understand early. The notified body reviews technical documentation on the device part, structured much like the Annex II technical documentation behind a CE marked device, and gives an opinion against the relevant GSPRs. In practice that means risk management to ISO 14971, design verification data (dose accuracy, actuation forces, needle extension, that sort of thing), usability and human factors work, drug and device compatibility, sterilisation validation, and packaging and stability evidence for the device side.
If that list sounds like a technical file, that’s because it more or less is one. The depth of evidence expected is the same, so the same discipline applies: requirements traced through to verification results, and reports written so a reviewer who wasn’t in the room can follow them.
The verification data is usually the long pole. It has to come from properly designed and documented test methods, often on bespoke rigs, and for delivery devices quite a bit of it comes down to force and displacement measurement. That’s work we do in our own workshop near Bristol, on a calibrated Mecmesin test machine with rigs we design and build ourselves. On the rugged autoinjector project we wrote the device documentation as the project went along, structured around what a notified body reviewer would want to see, which is a lot less painful than trying to assemble it retrospectively.
When to start (earlier than you’d think)
The notified bodies with combination product scope are a reasonably small group, and they get booked up. BSI, for one, describes the opinion process as typically taking two to six months depending on the quality of the initial submission and the number of question rounds, and it’s common for companies to make contact around nine months before they plan to submit. EMA has also recommended having the opinion available when the marketing authorisation application goes in, since a timing mismatch between the two reviews can hold up the approval.
It’s also worth knowing that significant changes to the device after approval need a fresh opinion as part of the medicines variation process, so design changes on a marketed combination product aren’t free, and it pays to get the device design properly settled and verified before the first submission.
The UK position
Article 117 itself is EU law, so strictly it applies to EU marketing authorisation applications. In Great Britain an integral drug-led combination is still regulated as a medicinal product, authorised by the MHRA, and you’ll still be expected to show that the device constituent is safe and performs as intended, so the same body of design and verification evidence gets used on both sides.
On the device side more broadly, CE marked devices remain accepted in Great Britain until 30 June 2028 for devices certified under the old directives, and 30 June 2030 for devices under the EU MDR. The MHRA ran a consultation on recognising CE marking indefinitely, which closed on 10 April 2026 with no outcome published as I write this, and it also published draft GB device regulations in spring 2026 covering international reliance, reclassification, UDI and implant cards, so the GB framework is moving. My view is that none of this changes the practical advice for combination product developers, which is to build the device evidence to the MDR GSPRs and keep it in good order, since it will serve the GB submission too. If you’re weighing up routes more generally, our piece on UKCA vs CE marking in 2026 covers the current position.
What this means for how you run the device work
For a development team it boils down to this. Agree the regulatory categorisation early, because whether the product is drug-led or device-led sets the whole framework. Then define exactly what the device constituent is and treat its documentation as a live part of the development. The requirements, the risk management and the verification plan should all exist in draft while the design is still moving, because the notified body review goes far more smoothly when the evidence has been accumulating all along.
That’s the shape of the work we do at MDIN. We design and prototype the device and run the bench testing, and we prepare the design and verification documentation in the form an Article 117 review expects. The rugged autoinjector programme linked above is a worked example. Only a notified body can issue the opinion itself, and no consultancy can promise what a reviewer will say. What we do is get the device part to that review in good shape, with the design settled and the testing and documentation complete.
If you’re developing a combination product and want a second pair of eyes on the device side, or you’re earlier on and want to plan the development with Article 117 in mind, I’d be happy to have a call. An initial chat is free and there’s no obligation. You can book one here.
Frequently asked questions
No. Article 117 covers single integral products only, where the drug and device form one product used exclusively in that combination. A device co-packaged with a medicine is a medical device in its own right and needs its own CE marking, with a full technical file behind it.
Only devices that would be Class I, non-sterile and non-measuring if sold separately escape the requirement, since those are self-certified. Very few integral delivery devices fit that description, since most are sterile or measure a dose, so in practice you should plan for an opinion.
BSI describes two to six months as typical, depending on the quality of the initial submission and the number of question rounds, and notified bodies are commonly contacted around nine months before the planned submission. It needs to be in the programme plan early.
Article 117 is EU legislation, so it applies to EU applications. The MHRA still expects the device constituent of an integral combination product to be shown safe and performing as intended, and CE marked devices are accepted in Great Britain until at least 30 June 2028, so in practice the same evidence supports both submissions. The GB rules are being updated, so it’s worth checking the current MHRA guidance early in the programme.
No. The opinion covers conformity of the device part with the relevant GSPRs for use in that specific combination product. It doesn’t result in a CE mark and it can’t be used to place the device on the market separately.