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 Medical Device Regulation (MDR) Annex XVI - How Can You Prepare?

What is the EU MDR Annex XVI?

Regulation (EU) 2017/745 on Medical Devices, known as the Medical Devices Regulation (MDR), came into force in May 2021. It replaced Medical Devices Directive 93/42/EEC (MDD) and Directive 90/385/EEC, which was for active implantable medical devices (AIMDD).

Annex XVI of the EM MDR regulation is for products that, whilst similar to a medical device in terms of its function and risk profile, have been designed for a non-medical or aesthetic purpose. These products have been incorporated into the MDR to ensure the health and safety of users.

The products have been classed into six broad groups:  

  •   Contact lenses or other items intended to be introduced into or onto the eye containing tools such as antenna or microchips. Examples include non-prescription colored contact lenses.
  •   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
  •   Substances, combinations of substances, or items intended to be used for facial or other subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing—for example, dermal fillers.
  •   Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty 
  •   High-intensity electromagnetic radiation emitting equipment intended for use on the human body, such as lasers and intense pulsed light (IPL) equipment for body hair removal
  •   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.

It is worth noting that this list could be amended by the European Commission to bring other products into scope in the future.


How will Annex XVI affect manufacturers? 

Manufacturers of Annex XVI products sold in Europe and the UK will have to be compliant with the requirements laid out in the MDR for general medical devices to ensure user safety. 

Compliance with the common specifications for these products will also need to be demonstrated. The common specifications are currently in draft form and therefore subject to change. They explain how these products should be assessed to demonstrate their safety and performance. They also address the application of risk management and, where necessary, clinical evaluation regarding safety. 

In essence, the regulation means that manufacturers of these products will have to meet stricter requirements, in line with other medical devices, to sell their products in the EU. In particular, the rules for conformity assessment procedures, which require the involvement of a Notified Body such as Element, have been tightened.


Manufacturer's legal requirements and obligations

As part of the legal requirements, manufacturers will need to pass a conformity assessment, if required, carried out by a notified body. They must then draw up a declaration of conformity and place a CE mark on the device. In addition, a basic unique device identifier (UDI) needs to be assigned and provided to the UDI database while key information about themselves, as well as the authorized representative and/or importer if they are based outside the EU, needs to be submitted to Eudamed, the electronic system. 

The manufacturer also needs to meet the post-market surveillance and vigilance requirements, including reporting serious incidents to the relevant authority, such as the MHRA in the UK.

In addition to complying with the relevant common specifications, manufacturers of Annex XVI products will have other obligations to meet, such as ensuring the device has been correctly classified against the new risk classification criteria in Annex VIII of the MDR. They will also need to ensure that a person responsible for regulatory compliance is in place, they have sufficient financial coverage for potential manufacturer liability, the new vigilance reporting timescales are met, and an annual periodic safety update report is created. 

Ensuring the product's distributors and importers have met their obligations set out in Articles 13 and 14 of the regulation is also the manufacturer's responsibility.


When is this coming into force?

Manufacturers of Annex XVI products must comply with the regulation within six months of the official publication of the common specifications, expected in Spring 2022. This means manufacturers need to be considering how this will affect their product(s) now and what additional testing and evidence will be necessary to comply. 


How can Element help?

An initial assessment of the upcoming changes by Element's team of experts has highlighted significant changes to both the regulatory and developmental pathway for such products, which will need to be addressed by manufacturers and require a different regulatory and test strategy.  

It is important to note that the MDR's general safety and performance requirements (GSPRs) may impact existing testing and evidence. Depending on the product, it is possible that existing testing undertaken for CE Marking to other legislation such as the LVD or EMC may be utilized in the conformity assessment. This will require careful evaluation taking into account medical device harmonized standards and common specifications. 

Element's team of medical device experts can help manufacturers understand the MDR's general safety and performance requirements relating specifically to their product and provide the necessary guidance regarding clinical data and post-market requirements. In addition, our team will work with you to ensure you have all the regulatory and contractual compliance evidence, including technical documentation, required of you.

Please get in touch with Element here for more information about Annex XVI of the Medical Devices Regulation and ensure your product(s) comply with the common specifications.

If you are interested in attending one of Element's upcoming workshops on the subject, please also contact us for more information.


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