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:

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:

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:

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


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.


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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