Annex XVI – Products Without an Intended Medical Purpose
Clinical Performance Studies under the IVDR – What’s required, what has changed?
General Background
According to regulation (EU) 2017/745, manufactures of Annex XVI products which are similar to medical devices in terms of function and risk profile, will be required to demonstrate compliance with common specifications (CSs) to ensure the safety and the performance of their products. These products are referred to as “products without an intended medical purpose” or “non-medical devices with a medical purpose.” Products that fall under Annex XVI include the following list below.
The manufacturer should address the collection and utilization of relevant sources including:
The following groups of products, listed in the EU MDR’s Annex XVI are:
- Contact lenses or other items intended to be introduced on or into the eye, 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, with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended for facial or other subcutaneous, submucous, or intradermal injection or other introduction, excluding those for tattooing. Examples include 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 (such as infra-red, visible light and UV) emitting equipment intended for use on the human body. Examples include lasers and intense pulsed light (IPL) equipment for tattoo or body hair removal.
- Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
The manufacturer should address the collection and utilization of relevant sources including:
Common specifications have been adopted by the commission, in December 2022 for Annex XVI products covering multiple aspects including commons specifications for:
- Risk management (including product specific hazards, risks and control measures)
- Labelling (content required in the instructions for use, and labels)
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
The manufacturer should address the collection and utilization of relevant sources including:
The requirements for Annex XVI products under the EU MDR include:
- Manufacturers of Annex XVI products must register their product with the relevant competent authorities in the European Union.
- Manufacturers must issue a declaration of conformity stating that their product complies with the requirements of the EU MDR.
- Annex XVI products must comply with the relevant applicable standards, including common specifications.
- Manufacturers must identify and manage the risks associated with their Annex XVI product, including any potential adverse effects on health.
- Manufacturers must establish a post-market surveillance system for their Annex XVI product to monitor its performance and identify and report any incidents or issues.
- Annex XVI products must be accompanied by appropriate labeling and instructions for use that provide clear and accurate information to users.
- In some cases, manufacturers may need to provide clinical evidence to demonstrate the safety and effectiveness of their Annex XVI product.
In summary, manufacturers of Annex XVI products must comply with the requirements of the EU MDR, including registration, declaration of conformity, compliance with applicable standards, risk management, post-market surveillance, labeling and instructions for use, and clinical evidence (where applicable). By complying with these requirements, manufacturers can ensure that their Annex XVI products are safe and effective for their intended purpose.
Our Services
Training
AKRA TEAM offers training on drafting technical documentation for Annex XVI products to meet the expectation of EU MDR and avoid common reasons for delays in technical documentation reviews by notified bodies.
Process and Templates Development
AKRA TEAM has proven procedure and document templates available for all aspects of the technical documentation.
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of technical documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians, quality and regulatory experts available to write all aspects of technical documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the technical documentation is currently under review AKRA TEAM can provide targeted updates based on any open deficiencies.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of technical documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU MDR.
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