Navigating conformity assessment routes in the MDR

Under Article 52 and Annexes IX through XI of the Medical Device Regulation (MDR), it is the legal manufacturer's responsibility to select the appropriate conformity assessment route.

However, as a Notified Body, we often observe confusion regarding what these assessments entail and which route is best. The correct choice depends on the device classification and the level of control the manufacturer maintains over design and production.

Below is a breakdown of the specific routes.

Note: Regardless of the route chosen, the manufacturer must draw up a Technical Documentation in line with Annex II and III of the MDR. This requirement applies to all devices, including self-certified Class I devices.

Annex IX Quality management system and Technical documentation Assessment

Annex IX is the route most commonly used and often the most efficient route regarding cost and, especially for lower risk devices, flexibility. It is considered the most suitable route for standalone medical device software (SaMD), since SaMD does not involve physical manufacturing, and the assessment of design procedures are highly relevant.

Annex IX consists of an assessment of your QMS, including design and production. It also includes review of one or more technical documentations. This is based on sampling in case of class IIa or IIb, and on a technical documentation assessment of every device in case of a class IIb implant or class III device. If conformity to the general safety and performance requirements and the MDR in general is shown, the manufacturer will obtain a QMS certificate, listing the device groups certified.

In case of a class IIb implant or class III device, also a Technical Documentation assessment certificate will be issued. In the first case (class IIa and class IIb non-implants), the conformity assessment is based on Annex IX without section 4, in the second case (class III and class IIb implants, except certain well-established technologies) conformity assessment is based on Annex IX with section 4.

For class I devices that are sterile, reusable or have a measuring function, the same approach applies, but the Notified Body will only assess the sterility, reuse or the measuring aspects.

When Annex IX is used for devices in risk class IIa and IIb (non-implants), the manufacturer is allowed to make certain changes that are not substantial changes to the quality management system or the device-range covered (please note that there can still be changes that need to be notified, even if not substantial, because they could for example affect the TD sampling scheme). For class IIB implants and class III however, all changes that could affect the safety and performance of the device or the conditions prescribed for use of the device need to be pre-approved by the Notified Body.

Annex X Type-examination

Annex X is not a stand-alone route; it does not grant permission place a device on the market in itself. It must be followed by either Annex XI part A or part B. Annex X conformity assessment is focused on one device type (covered by one Basic-UDI) only. The device type, and its related technical documentation, can cover multiple variants, but only if they have the same intended purpose, risk class and essential design and manufacturing characteristics. Annex X is applicable to class IIb and class III devices.

Annex X type examination will consist of a technical documentation assessment and appropriate assessments and physical or laboratory testing, to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements and/or relevant standards have been actually applied. If the device type is in conformity, a Type-Examination certificate will be issued.

When Annex X is applied, the manufacturer needs to obtain pre-approval for all changes that could affect the safety and performance of the device or the conditions prescribed for use of the device, even if the device is a class IIb non-implant.

Annex XI part A Production quality assurance

This conformity assessment route is comparable to Annex IX, with the exception that the quality system covers manufacture, but not design. This route can therefore be useful for manufacturers that have outsourced the design (though the manufacturer remains fully responsible of the outsourced design activities).

For class IIa devices it can be used as the sole conformity assessment route, but for class IIb and III it must be combined with Annex X. In case of class IIa devices, the technical documentation will be sampled, and the legal manufacturer is required to have full control over the technical documentation. If in conformity, a Quality Assurance certificate will be issued. The same requirements on change notification are applicable as per Annex IX (however for class IIb and III, the stricter rules of Annex X should be followed for device-related changes).

Annex XI part B Product Verification

In this conformity assessment route, the Notified Body must examine every device, before it can be released to the market. The manufacturer is not required to undergo an audit to the quality management system, but be aware that the MDR still requires that a quality management system according to article 10 is in place.

Previously, under MDD, this could be done on a sampling base, but under MDR every single device needs to be fully tested. This makes this conformity assessment less cost-effective and efficient in most instances, unless a legal manufacturer releases only a single device per year or multiple years. Even then, a thorough consideration of costs is in place, since testing will often take multiple days and will involve the need for traveling of a test team of the Notified Body to the test location.

For class IIb and class III, this conformity assessment route needs to be accompanied by a valid Annex X certificate. Certificates resulting from Annex XI, part B conformity assessment are linked to specific, individual devices.