Annex XVI – EU MDR

What is an Annex XVI product?

Annex XVI products are those for which a manufacturer claims only an aesthetic or another non-medical purpose but are like medical devices in terms of functioning and risk profile.

These categories of products were added in the new Regulation to establish production and surveillance standards for these previously unregulated products to protect users’ health and safety.

LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)

1. Contact lenses or other items intended to be introduced into or onto the eye.
2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts except for tattooing products and piercings.
3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
4. Equipment intended to be used to reduce, remove, or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
5. High-intensity electromagnetic radiation (e.g., infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad-spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

When is this coming into force?

Manufacturers of Annex XVI products have six months from the official release of the standard specifications, which is scheduled in Spring 2022, to comply with the regulation.

As a result, manufacturers must examine how this may affect their product(s) right now and what further testing and proof will be required to demonstrate compliance with common specifications.

Technical and clinical requirements (other than standards) that give a way of complying with the legal duties applicable to a device are referred to as “common specifications.” Existing harmonised standards for similar medical equipment will be considered.

Annex XVI products do not have to comply with the MDR until the Commission adopts and publishes the CS for the individual product categories, which is expected to be no later than May 26, 2020,  or when CS is adopted, whichever is the latest.

Individual Member States’ national classification of Annex XVI products as medical devices will continue to apply until then, and compliance with applicable national medical device legislation will be required.

How will this impact manufacturers of these products?

Manufacturers of Annex XVI products sold in Europe (including the UK) will have to be compliant with the requirements laid out in the MDR for general medical devices to ensure they are safe for use.

In addition to complying with the relevant standard specifications, manufacturers of Annex XVI products will need to meet several other obligations such as GSPR, equivalence approach, clinical data, and post-market surveillance.

These include, but are not limited to, ensuring that: 

• Correct classification of the device based on the risk impact (as per Annex VIII)
• Comply to the Common Specifications listed for those products
• Require demonstrating clinical benefit in accordance with Annex XIV & annex XV
• There is a person in charge of regulatory compliance
• Distributors and importers in the supply chain are compliant
• Sufficient financial coverage is in place in respect of a manufacturer’s potential liability
• The new vigilance reporting deadlines have been met, and an annual safety update report has been issued.

Manufacturers must undergo a conformity assessment, which will be conducted by a notified authority, as part of the regulatory requirements.

The device must then be marked with a CE mark and a declaration of conformity. Furthermore, a basic unique device identification (UDI) must be assigned and provided to the UDI database, critical information about themselves, and the authorised representative and importer if they are based outside of the EU, needs to be submitted to EUDAMED.

The manufacturer must also comply with post-market surveillance and vigilance requirements, including reporting remarkable events to the appropriate authorities, such as the MHRA in the UK.

Manufacturers of Annex XVI products will have additional requirements, such as verifying that the device has been accurately classified against the revised risk classification criteria in Annex VIII of the MDR and complying with the necessary standard specifications.

They will also need to ensure they have a person in charge of regulatory compliance, have enough insurance to cover potential manufacturer liability, meet the new vigilance reporting deadlines, and generate an annual periodic safety update report.

The manufacturer is also responsible for ensuring that the product’s distributors and importers have performed their duties under Articles 13 and 14 of the regulation.

Please read Article 10 of the MDR for further detail on manufacturer obligations.

 

How to comply with the legal requirements?

• Determine which risk category your device belongs to.
• Ensure your device conforms with the MDR and the standard specifications for these groups of products.
• Pass a compliance assessment conducted by a notified body if required.
• Draw a declaration of conformity and affix a CE mark to the device.
• Provide the UDI database with a basic unique device identification (UDI) assigned to the device.
• If the manufacturer is outside the EU, submit essential information about the manufacturer, authorised representative, and importer to the electronic system (Eudamed).
• Place your CE marked device on the market or put it into service anywhere in Europe.
• Meet the standards for post-market surveillance and vigilance, such as implementing field safety remedial actions and reporting major events to the appropriate authority.

Examples of Annex XVI products

• Non-prescription coloured contact lenses
• Solid contour body implants
• Dermal fillers
• Liposuction body sculpting equipment
• Equipements for hair removal (using infra-red, ultraviolet, visible light)
• Transcranial simulator

FAQs (Frequently Asked Questions)

Devices with non-medical purposes are classified under which rule?

Apply Annex VIII classification rules in the EU MDR.

Do I need an Authorised Representative for marketing devices without intended medical purpose?

Yes, as per Regulation an AR must be appointed to sell these devices in the Union market.

Have the Common Specifications been released?

No, as of the date Apr 2022 the CS are under the draft stage. Follow our website updates to know more about this or subscribe to our newsletter to get the updates.

 Useful link: Guidance on Annex XVI