Drug-Device Combination Products Training Course
€339.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Art. 1(8), 1(9), 117 · Directive 2001/83/EC · 21 CFR Parts 3 and 4
Drug-Device Combination Products: EU MDR and FDA Requirements
Both systems, from qualification to post-market — every requirement stated with its article, and the document each one obliges you to hold.
€339
VAT calculated at checkout
27 modules · 8h 15 · workbook
· handbook · certificate
Access does not expire
Four ways a combination product file goes wrong
The product is placed in the wrong framework, because the principal intended action was asserted rather than demonstrated, and Article 2(2) of Directive 2001/83/EC resolves any doubt towards the medicine. The device part of an integral product reaches the marketing authorisation dossier without the document point 12 of Annex I requires, or with a notified body opinion that concludes on partial compliance.
A change to the ancillary substance or to the device is made without the consultation or the new opinion it triggers. And the same product goes to FDA with a risk file, a human factors study and a standards register that were built for one system and cannot be read by the other.
None of these are hard problems. They are the consequence of reading the two regimes as separate lists of rules rather than as one set of artefacts that a notified body, a medicines authority and FDA each read from their own side.
- 27 modules
- 8h 15 of video
- Self-paced
- Workbook included
- Handbook included
- Certificate on completion
- Access does not expire
Scope
What the course covers
The Union rules in force — MDR Articles 1(8), 1(9) and 117, Annex IX §5.2 and §5.4, the EMA questions and answers and quality guideline — set against 21 CFR Parts 3 and 4, with the 2026 pharmaceutical package as adopted by the Council at first reading. Where something is an interpretation rather than a rule, the course says so.
01
Qualification and the device-led route
The two definitions and the doubt rule, the four Union outcomes, primary mode of action and the request for designation, MDCG 2022-5, Rule 14 and the consultation of a medicines authority, Rule 21 and substance-based devices.
02
The drug-led route: Article 117
Amended point 12, the class of the device part if used separately, the declaration, certificate or notified body opinion, the Team-NB template, the EMA quality guideline, co-packaged devices and changes after authorisation.
03
Evidence, the US lifecycle and what comes next
ISO 11608 and ISO 11040, extractables and leachables, risk management, human factors, clinical bridging, US premarket pathways, Part 4 cGMP and postmarket reporting, UDI, followers, the UK and Switzerland.
Outline
27 modules, in the order the process runs
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.
What is included
What you get when you buy
- 27 video modules, 8h 15 in total
- A downloadable transcript for every module
- A test at the end of each module, and a final test
- The workbook, as a PDF — a structured review of your own combination product file
- The handbook, as a PDF — a standalone regulatory guide in 27 chapters, organised by legal text
- A certificate with a verifiable code
- Every future revision of the course, at no further cost
The certificate
On passing the final test the certificate carries a 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 ISO 13485 §6.2.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
Does the course cover both device-led and drug-led products?
Yes. One part covers devices with an ancillary medicinal substance and substance-based devices; another covers integral and co-packaged products governed by the medicines framework. The technical modules apply to both.
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.
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.
Do I need copies of the ISO standards?
No. The course explains what ISO 11608, ISO 11040 and the other standards require and where each requirement sits, with clause references, but does not reproduce their text, which is protected by copyright. A copy open next to the relevant modules is useful if you are working on a submission.
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. It can be read without watching the course.
Is the course live, or can I start whenever I want?
It is self-paced. You start when you buy it and work through it at your own speed, from any device. There are no scheduled sessions and no cohort.
How long do I have access?
Access does not expire. The course is tied to your account, and modules updated after your purchase are available to you at no additional cost.
What does the certificate confirm?
That you completed the course and passed the final test. It carries a verification code derived from your name and the date, which anyone can check on a public page. It can be filed as training evidence under your quality management system.
What happens if I do not pass a test?
You can take it again. The rules for each test are shown on screen before you start it.
Can my company buy several seats?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
Drug-Device Combination Products
27 modules, 8h 15 of video, downloadable transcripts,
workbook, handbook and certificate. Self-paced, with no expiry.
€339.00
