EU MDR Art. 1(8), 1(9), 117 · DIRECTIVE 2001/83/EC · 21 CFR PARTS 3 AND 4 · EMA Q&A
Drug-Device Combination Products: EU MDR and FDA Requirements
A prefilled syringe meets two definitions at once. In the Union one framework governs it and the other reaches into the part that is not its own; in the United States it stays a combination product, with one lead center and both sets of requirements. This course takes both systems from qualification to post-market, states every requirement with its article, and shows the document each one produces.
Scope
What the course covers
Where a requirement is quoted, it is quoted in full and then explained. Where something is an interpretation rather than a rule, the course says so.
01
Qualification, in both systems
Articles 1(8) and 1(9) of the MDR and the four Union outcomes; 21 CFR Part 3, primary mode of action and the request for designation; MDCG 2022-5 on borderline products; the cases where the two systems give different answers.
02
Device-led: the ancillary substance
Rule 14 and the consultation of a medicines authority under Annex IX §5.2: the dossier, the 210 and 60-day clocks, changes to the substance, and the first consultation under the MDR. Rule 21 and the §5.4 consultation for substance-based devices.
03
Drug-led: Article 117
The amended point 12 of the medicines Directive, the declaration, certificate or notified body opinion it requires, the EMA questions and answers, the Team-NB opinion template, the EMA quality guideline section by section, co-packaged devices and changes after authorisation under section Q.IV.
04
The technical evidence
Device standards, extractables and leachables, risk management with severity taken from the medicine, human factors on the whole user interface, and the bridge from the device used in the trial to the device placed on the market.
05
The United States lifecycle
Premarket pathways and the lead center, 21 CFR Part 4 Subpart A after the QMSR, postmarket safety reporting under Subpart B, and device identification by configuration.
06
What comes next
The 2026 pharmaceutical package as adopted by the Council, follower products with a device, and the position in the United Kingdom and Switzerland.
Outline
27 modules, in the order the process runs
The course follows the sequence of the work rather than the numbering of the regulation, and ends where the work ends.
Introduction
Two regimes, one product, and how the course is arrangedWhy combination products are regulated twice
Two definitions, the doubt rule, the four Union outcomesEU definitions: integral, exclusive-use, co-packaged
The terms, their sources, and what is excludedUS definitions and primary mode of action
21 CFR 3.2, 3.4 and the request for designationBorderline and classification
MDCG 2022-5, Rule 14, Rule 21Rule 14 and the consultation procedure
Annex IX §5.2, national authority or EMAThe consultation dossier
Five sections, usefulness, master filesChanges to the ancillary substance and lifecycle
§5.2(f), MDCG 2020-12, the first MDR consultationSubstance-based devices vs ancillary substance
Rule 21, Annex I §12.2, Annex IX §5.4Article 117: text, scope, obligations
Point 12, the class if used separately, three documentsThe EMA questions and answers on Article 117
Section 2, question by questionThe notified body opinion process
The Team-NB file structure and opinion templateThe EMA quality guideline
Module 3 section by section, and 3.2.RCo-packaged and referenced devices
Article 16, Article 120, the divided packDevice changes after authorisation
Q&A 4.1 and 4.2, section Q.IVThe 2026 pharmaceutical package
The Council text: definitions, Articles 19 to 21, 58(6)Injection and delivery device standards
ISO 11608, ISO 11040, the GSPR tableDrug-device compatibility
Extractables, leachables, container closure integrityRisk management for the combined product
Essential drug delivery outputs, the bridge tableHuman factors for combination products
Critical tasks, validation, three reviewersClinical and performance evidence
From the trial device to the marketed deviceUS premarket pathways
One application, the lead center, the consultUS cGMP: 21 CFR Part 4 Subpart A
The streamlined approach after the QMSRPostmarket safety reporting
Part 4 Subpart B and the EU systemsUDI and labelling
Which identifier, on which surfaceGenerics and biosimilars with devices
Comparative analyses, Article 117 for followersUK and Switzerland
Two more markets, and the course in one tableFinal test
Covering the whole courseOutcomes
What you will be able to do
01
Place a product in both systems
State the Union provision and the United States type for any combination, with the data behind the principal action and the primary mode of action.
02
Run the consultation for an ancillary substance
Choose the medicines authority, build the five-section dossier, and manage changes to the substance within the 60-day route.
03
Obtain the right Article 117 document
Classify the device part as if used separately, and know when a declaration, a certificate or a notified body opinion is required — and why a partial opinion is refused.
04
Build the technical evidence once
One standards register, one compatibility programme, one risk file with a bridge table, one human factors study, each read by the notified body, the medicines authority and FDA.
05
Manage the lifecycle
Classify a device change under section Q.IV, decide whether a new opinion is needed, and route every safety event to the systems that must receive it.
Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every module replayable. Transcripts are downloadable, so the content stays searchable long after the video is finished. Access does not expire, and revisions made after your purchase are included.
Audience
Who the course is for
- Regulatory affairs professionals working on integral, co-packaged or device-led combination products
- CMC and quality staff responsible for the device sections of a marketing authorisation dossier
- Device manufacturers supplying the device part of a medicinal product
- Notified body personnel and consultants preparing or assessing opinions under Article 117
- Teams taking the same product to the European Union and the United States
It assumes familiarity with medical device regulation and with a quality management system. It does not assume prior study of the articles and annexes it covers.
Certificate
Verifiable by a third party
On passing the final test, the certificate carries a verification code derived from your name and the date of completion.
An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under your quality system.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you enrol
Does the course cover both device-led and drug-led products?
Yes. Part B covers devices with an ancillary medicinal substance and substance-based devices; Part C covers integral and co-packaged products governed by the medicines framework. The technical modules apply to both.
How does it treat the 2026 pharmaceutical package?
Module 15 sets out the new Directive and Regulation as adopted by the Council at first reading, with every deadline counted from entry into force. Until the new Directive applies, the rules in force are those of modules 09 to 14.
Is the United States covered in full?
The qualification rules of 21 CFR Part 3, the premarket pathways, Part 4 on cGMP and postmarket safety reporting, and device identification. Each EU topic is set against the corresponding US requirement.
Is the handbook a summary of the videos?
No. It is a standalone regulatory guide organised by legal text rather than by module, with the requirements quoted where the texts are verified, and it can be read without watching the course.
How long do I have access?
Access does not expire. The course stays in your account, including any updates made to the modules after your purchase.
Is there a certificate?
Yes. Passing the final test issues a certificate with a verification code, which anyone can check on our verification page.
Can I watch the modules in any order?
The modules unlock in sequence, because each one builds on the previous. Once unlocked, a module stays available and can be rewatched.
Do I need any prior knowledge?
The course assumes you work in the sector and know what a technical file and a notified body are. No knowledge of the specific technology is assumed.
Can my company buy several seats?
Yes. Write to us and we will set up team access with a single invoice.
Enrol
From the first qualification decision to the safety report — both directions, both systems.
27 modules, 8h 15min of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.