Annex XVI: Devices Without a Medical Purpose
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR ANNEX XVI · REGULATION (EU) 2022/2346 · REGULATION (EU) 2022/2347 · MDCG 2023-5
Annex XVI: Devices Without a Medical Purpose
A fourteen-module video training course on the certification of products that have no medical purpose, so you can qualify a product, classify it, find its deadline and build the file the common specifications require.
€229
VAT calculated at checkout
14 modules · 2h 15 of video · Certificate
Access does not expire
A 14-module video training course on Annex XVI certification
Fourteen modules, 2h 15 of video, on the six groups of products listed in Annex XVI of the Medical Device Regulation: non-corrective contact lenses, implants for aesthetic purposes, dermal and mucous membrane fillers, adipose tissue equipment, high intensity light and laser equipment, and brain stimulation equipment. Each module has a quiz; the course includes a workbook, a handbook and the slides as PDF.
What you learn to do: qualify a product against the six group descriptions, classify it under Annex VIII as modified by the reclassification regulation, identify which of the five transitional cases applies and by when, build the risk management file and the information for safety that the common specifications require, apply the specific requirements of your product group, and choose a clinical evaluation route that MDCG 2023-6 allows.
Why it is needed: these products had no device framework before 22 June 2023, and the one that now applies to them does not work like the rest of the Regulation. There is no definition of an Annex XVI product, two classification rules cannot be applied to them, there is no clinical benefit to weigh risk against, and equivalence with a medical device cannot be demonstrated. The transitional dates adopted in December 2022 were replaced six months later, and the originals are still in circulation; this course uses the consolidated text.
- 14 modules
- 2h 15 of video
- Self-paced
- Workbook included
- 63-page handbook
- Certificate on completion
- Access does not expire
Scope
What the training course covers
The course follows the structure of the texts themselves: the general framework first, then one module for each of the six product groups in the order of the annexes, then the evidence and the procedure. Every requirement is quoted by article or section number in the module that covers it.
01
Qualification, class and deadline
How a product is qualified against the six group descriptions, which class it takes under Annex VIII as modified by the reclassification regulation, and which of the five transitional cases applies to it, with the dates in force rather than the ones adopted in 2022.
02
The common specifications, group by group
Annex I, which applies to all six groups: the risk management process and the criterion for risk acceptability where there is no clinical benefit. Then Annexes II to VII, one module each, with the specific risks, the specific control measures and the prescribed wordings of each.
03
Clinical evaluation and conformity
What Article 61(9) requires in place of clinical benefit, which equivalence comparisons MDCG 2023-6 allows and which it rules out, and the conformity assessment, identification, registration and surveillance obligations that follow.
Outline
14 modules, in the order the texts are built
Audience
Who the training course is for
- Regulatory affairs managers placing an Annex XVI product on the European market
- Quality managers at aesthetic device manufacturers facing a device framework for the first time
- PRRC and persons responsible for regulatory compliance
- Consultants qualifying borderline products or remediating files
- Notified body personnel assessing products in these six groups
- Distributors and importers who need to know what the product they carry is
The course assumes you know the structure of the Medical Device Regulation and what a technical file, a notified body and a risk management process are. It assumes no prior work on Annex XVI products, because for most manufacturers in these sectors there is none.
What is included
What you get when you buy
- 14 video modules, 2h 15 of video, self-paced
- A quiz after every module, four or five questions each
- A final test of 20 questions covering the whole course
- A 21-section workbook that runs a gap analysis on your own file, with one section per product group
- A 63-page handbook in fourteen chapters, written to be read on its own
- The slides of every module as PDF
- Certificate on completion, with a verification code
- Access that does not expire
The certificate
Issued on passing the final test. It records the course, the date and the holder, and carries a code that anyone can check against the register — an employer, an auditor, or a client asking what your team has been trained on.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
Is my product covered by Annex XVI?
That is the question module 01 answers. There is no definition of an Annex XVI product in the Regulation, so qualification is a comparison against the six group descriptions and the scope sections of the common specifications, on five characteristics. The module also covers the products that look as if they belong and do not, with the reason given for each in MDCG 2023-5.
Does the course cover all six groups?
Yes, one module each, following the corresponding annex: the specific risks, the specific risk control measures, and the label and instructions content. You will work through the one that applies to your product and can read the others as reference.
Which version of the transitional dates does it use?
The consolidated text. The dates adopted in December 2022 were replaced by Implementing Regulation (EU) 2023/1194 in June 2023, and the course gives both, so the superseded ones can be recognised where they still appear.
Do I need copies of the regulations to follow it?
No. Every requirement is quoted by article or section number on the slide that covers it, and the slides are included as PDF. You will want the texts themselves when you come to write your own file, because it has to cite them.
Is this a course or a documentation kit?
A training course. Fourteen video modules with quizzes, a workbook and a handbook. There is no document template set for Annex XVI products at the moment; the workbook tells you what your own file needs to contain, section by section.
How does it differ from a general MDR course?
It covers only what is specific to Annex XVI. The general regime — quality management, technical documentation, post-market surveillance — appears where it differs for these products or where a specific obligation attaches, not from the beginning.
Is it live or self-paced?
Self-paced. The modules run five to fifteen minutes each and open in sequence, because each one uses the outputs of the previous. Once opened, a module stays available.
Can I watch part of it before buying?
Module 00 is free. It covers what Annex XVI does, which texts the course is built on, and how the fourteen modules are arranged. About five minutes.
What happens if I fail the final test?
You retake it. There is no limit and no waiting period, and the questions cover the same ground as the module quizzes, so the modules where you lost marks are the ones to rewatch first.
Can I buy several seats for a team?
Yes. Contact us before purchasing and we will set the seats up under one invoice, with the certificates issued individually.
Annex XVI: Devices Without a Medical Purpose
A fourteen-module training course, 2h 15 of video, with a 21-section workbook and a 63-page handbook. Self-paced, certificate on completion, access does not expire.
€229.00
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