Devices without an intended medical purpose — Annex XVI of the MDR: scope and compliance
Your products are not medical devices… and yet, since 22 June 2023, some of them are subject to Regulation (EU) 2017/745. Coloured contact lenses, body implants for aesthetic purposes, dermal fillers, intense pulsed light hair-removal devices: Annex XVI of the MDR has redrawn the boundaries of the regulatory scope. This one-day course gives you the keys to qualify your products, determine your compliance pathway, and master the applicable common specifications.
Audience Regulatory affairs managers and officers, marketing managers, product managers, and general managers of companies operating in the medical aesthetics, wellness, or technical cosmetics sectors whose products may fall under Annex XVI of MDR 2017/745.
Learning objectives
- ▸ Identify the six product families listed in Annex XVI of the MDR and apply the qualification criteria to your own product ranges
- ▸ Distinguish the applicable compliance pathways according to the product's classification (class IIa, IIb, III) and determine whether or not a notified body is required
- ▸ Interpret the common specifications established by Implementing Regulation (EU) 2022/2346 and its amendment (EU) 2023/1194, particularly with regard to risk management and user information
- ▸ Apply the principles of the ISO 14971 risk management process to products without an intended medical purpose covered by Annex XVI
- ▸ Use the MDCG 2023-5 (qualification) and MDCG 2023-6 (demonstration of equivalence) guidance documents in building a compliance file
- ▸ Incorporate the extended transitional provisions (until 31 December 2028 or 2029) into the company's commercial and regulatory planning
Expected outcomes
- ✓ At the end of the session, each participant is able to rule on the regulatory scope of their products, define an Annex XVI compliance roadmap, and engage effectively with a notified body or an external RA service provider.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
A general knowledge of the regulatory framework for medical devices is recommended. The IA-REG-01 course (MDR Fundamentals) or IA-REG-02 (Manufacturer's obligations under the MDR) may be taken beforehand.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This course is not Qualiopi-certified and is not eligible for funding via the OPCOs
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Scope of Annex XVI: understanding why these products are concerned (1 h)
- ·Recap of Article 1(2) of the MDR
- ·The six product families of Annex XVI
- ·Risk criteria comparable to medical devices
- ·Concrete examples: coloured contact lenses, implants for aesthetic purposes, injectable fillers, intense pulsed light hair-removal devices, cosmetic lasers, liposuction
- 02
Classification and conformity assessment procedures (1 h 30)
- ·Application of the classification rules of Annex VIII to Annex XVI products
- ·Determination of the class (IIa, IIb, III)
- ·Identification of the applicable conformity assessment procedures
- ·The case of dual-use products (medical and non-medical intended purpose)
- ·Role of the notified body according to the class
- 03
Common specifications: Regulation (EU) 2022/2346 and its amendment 2023/1194 (2 h)
- ·Structure and articulation with Annex I of the MDR
- ·General risk management requirements common to all Annex XVI products
- ·Specific requirements by product group (Annexes II to VII of the implementing regulation)
- ·Information to be provided to the user
- ·The mandatory "non-medical purpose" statement on the labelling
- 04
MDCG 2023-5 and 2023-6 guidance documents: qualification and demonstration of equivalence (1 h)
- ·MDCG 2023-5: elements useful for qualifying a product under Annex XVI
- ·MDCG 2023-6: demonstration of equivalence based on an existing device for CE marking
- ·Articulation with MDCG 2020-5
- 05
Transitional provisions and commercial planning (45 min)
- ·Extension until 31 December 2028 or 2029 depending on the conditions
- ·Keeping on the market products subject to the involvement of a notified body
- ·Practical implications for the product roadmap and marketing decisions
- 06
Practical case workshop and individual action plan (45 min)
- ·Qualification exercises on real products
- ·Building a compliance checklist
- ·Identification of documentary gaps
Assessment of learning
Assessment methods
A 20-question QCM at the end of the day covering the qualification of Annex XVI products, the common specifications, and the conformity assessment procedures. Results are communicated individually.
Certificate
Training certificate issued by Isofac Group at the end of the course, subject to full participation in the session. This certificate does not constitute a certification recognised by the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Training slides
- ·Summary sheets of the six Annex XVI product families
- ·Comparative table of conformity assessment procedures by class
- ·Complete references of the regulatory texts and MDCG guidance documents
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This course is not Qualiopi-certified and is not eligible for funding via the OPCOs
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.