MDR Annex XVI products and Common Specifications (CS)

a young doctor conducting tests under a microscope

What is MDR Annex XVI?

Annex XVI of EU MDR 2017/745 covers specific product groups that do not have a medical intended purpose, yet are used on the human body and inherently carry certain risks.

Although these products are not intended for diagnosis or treatment, they are included within the MDR framework due to their potential impact on human health and safety.

Through this approach, the European Union aims to:

Enhance user and patient safety
Establish a harmonized conformity assessment framework for such products

At Kiwa, we closely follow these regulatory developments and support manufacturers in aligning their products with MDR requirements from early stages.

Equipment emitting high-intensity electromagnetic radiation

e.g. lasers and intense pulsed light (IPL) systems

Devices intended for reducing, removing, or shaping adipose tissue

e.g. cryolipolysis, ultrasonic or radiofrequency lipolysis devices

Devices used for brain stimulation

e.g. transcranial magnetic or electrical stimulation equipment

Even if these products are not marketed as medical devices, they may produce significant and potentially irreversible effects on the human body, which justifies their inclusion under MDR.
Kiwa supports manufacturers in determining whether their products fall under Annex XVI and how to position them correctly within the regulatory framework.

CS documents define clear expectations for manufacturers in areas such as:

Product design and technical safety requirements
Risk management approach
Clinical evaluation and level of clinical evidence
Instructions for use and user information
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)

In essence, CS represent mandatory baseline requirements, distinguishing them from voluntary harmonized standards.

Kiwa provides structured assessment services to verify compliance with these CS requirements, ensuring that manufacturers meet both technical and clinical expectations.

Why are Common Specifications mandatory?

For Annex XVI products:

Harmonized EN standards may not be sufficient
Clinical risks often require product-specific evaluation
The user profile (often non-medical users) necessitates additional safety measures

Therefore, CS go beyond manufacturer self-declaration and establish a framework that requires independent assessment by a Notified Body.

As a Notified Body, Kiwa plays a key role in ensuring that these requirements are applied consistently and effectively.

Classification and role of the Notified Body

Many Annex XVI products are classified as Class IIa, IIb, or III under applicable implementing regulations.
This leads to the following implications:

Mandatory involvement of a Notified Body
Detailed assessment of technical documentation, clinical evaluation, and risk management files
Verification that the device achieves its intended performance while minimizing risks

This process ensures an independent and objective evaluation of user safety.

Kiwa performs these assessments with a focus on regulatory compliance, technical robustness, and patient safety.

What does Kiwa provide as a Notified Body?

As Kiwa, we offer:

Conformity assessment services aligned with MDR Annex XVI and CS requirements
Verification of product classification
Review of technical documentation and clinical files
Assessment of pre-market and post-market safety requirements

Our approach combines regulatory expertise, sector knowledge, and practical audit experience to support manufacturers throughout the conformity assessment process.