Annex XVI · Regulation (EU) 2022/2346 · Regulation (EU) 2022/2347
Annex XVI: Devices Without a Medical Purpose
Six groups of products that have no medical purpose, regulated as devices since June 2023 — and the common specifications that say what their technical documentation has to contain.
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 and classification
The Regulation provides no definition of an Annex XVI product: qualification runs on the group descriptions and on the scope sections of the common specifications. Two classification rules presuppose a medical purpose and cannot be applied, which is why a second implementing act reclassified three of the six groups.
02
The transitional provisions, in the consolidated text
Five cases, each with its own end date and its own intermediate deadlines. The dates adopted in 2022 were replaced in June 2023 and the originals still circulate; the course uses the text in force.
03
Annex I: one process for all six groups
The risk management process required of every product, and the criterion for risk acceptability that applies where there is no clinical benefit to weigh a risk against. Then the second half of Annex I: what may not be claimed, what the label must bear, and the five contents of the instructions for use.
04
The six groups, one module each
Contact lenses, implants, dermal fillers, adipose tissue equipment, high intensity light and laser equipment, and brain stimulation equipment — with the specific risks, the specific control measures and the prescribed wordings of each annex.
05
Clinical evaluation without a clinical benefit
Article 61(9) replaces clinical benefit with performance. MDCG 2023-6 sets out which equivalence comparisons can be demonstrated and which cannot, and the course works through all three.
Outline
14 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
What Annex XVI does, and how the course is organisedScope and qualification
Article 1(2), the six groups, dual-purpose productsClassification and reclassification
Annex VIII and Regulation (EU) 2022/2347Transitional provisions
Five cases, their end dates and their deadlinesCommon specifications: risk management
Annex I, Sections 1 to 8Common specifications: information for safety
Annex I, Sections 9 to 12Group 1: Contact lenses
Annex II, and the Master UDI-DI ruleGroup 2: Implants
Annex III, and the consumer annexGroup 3: Dermal and mucous membrane fillers
Annex IV, and the treatment recordGroup 4: Adipose tissue equipment
Annex V: liposuction, lipolysis, lipoplastyGroup 5: High intensity electromagnetic radiation equipment
Annex VI: professional use and home useGroup 6: Brain stimulation equipment
Annex VII, and the excluded categoriesClinical evaluation and clinical investigation
Article 61(9), Annex XIV and MDCG 2023-6Conformity assessment and post-market obligations
Article 52, UDI, EUDAMED, surveillance and vigilanceFinal test
Covering the whole courseOutcomes
What you will be able to do
01
Qualify a product against Annex XVI
Compare it on the five characteristics the guidance sets out, against both the group description and the scope section of the corresponding annex, and handle the cases where two purposes or two groups apply.
02
Identify the class and the applicable transitional case
Apply Annex VIII and the reclassification regulation to every item placed on the market, and determine which of the five transitional cases the product falls into, with its end date and its intermediate deadlines.
03
Build the risk management file the common specifications require
The policy, the plan, the analysis and the control records, with the acceptability criterion of Section 3.3 and the justification it requires where that criterion is not met.
04
Produce the label and the instructions for use
The general requirements of Annex I and the additions of the group annex, including the wordings that are prescribed word for word and the annex handed to the consumer before treatment.
05
Choose and defend a clinical evaluation route
Clinical investigation, equivalence with another product without a medical purpose, or equivalence with a dual-purpose device — and what remains usable when equivalence cannot be demonstrated.
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 and quality professionals placing an Annex XVI product on the European market
- Manufacturers of aesthetic devices facing a medical device framework for the first time
- Notified body personnel and consultants assessing these products
- Anyone holding a product that is covered by a group description and has to determine what follows
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 all six groups?
Yes. One module for each, following the corresponding annex of the common specifications: the specific risks, the specific risk control measures, and the label and instructions content.
Which version of the transitional dates does the course use?
The consolidated text. The dates adopted in December 2022 were replaced by Implementing Regulation (EU) 2023/1194 in June 2023, and the course states both, so that the originals can be recognised where they still circulate.
Do I need to know the general MDR regime first?
The course assumes familiarity with the structure of the Regulation and with risk management practice. It does not assume any prior work on Annex XVI products.
Is the handbook a summary of the videos?
No. It is a standalone regulatory guide of fourteen chapters, organised for reference rather than following the module order, 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.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook included with the course is a gap analysis of your own documentation, arranged in the order an assessment runs. Working through it produces a list of what is missing or partial in your file.
That list maps to the templates in the .
Enrol
From qualification to the post-market loop — the common specifications, group by group.
14 modules, 2h 15min of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.