MDCG 2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of IVDR

For class D devices, article 48(6) of the IVDR establishes conditions to be applied by the notified body to determine whether it must consult the expert panel on the performance evaluation report of the manufacturer. These conditions are:

  1. the absence of common specifications for the class D device in question,

    AND

  2. where it is also the first certification for that type of device.

This guidance provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body.

“The first certification for that type of device” is to be understood as the first certification under either IVD Directive 98/79/EC (IVDD) or the IVDR 2017/746 (IVDR) by any notified body in relation to a product with a specific:

  • intended purpose; and
  • analysis technology and process used.

Once a device with a specific set of elements has been certified either under the IVDD or IVDR, any other device to be certified for the first time under the IVDR with a similar set of elements will be considered the same “type of device” irrespective of the manufacturer and therefore will not need to be subject to a consultation with the expert panel. It is up to notified bodies to determine whether a certification is the first for a type of device.

The document also provides a template for notified bodies to follow for describing the type of a device when consulting with the expert panel. If a notified body is presented with an IVD that would be the first certification for that type of device, but the expert panel is already amid a consultation on a similar device, the notified bodies should wait to issue a certificate until the consultation is complete.

MDCG 2021-23 Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of MDR and IVDR

Article 16(3) of MDR / IVDR introduces requirements on the quality management system (QMS) to be established by distributors and importers carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) concerning relabelling and repackaging of devices. Article 16(4) of the MDR / IVDR provides for a notified body to certify that the QMS of the distributor or importer complies with the requirements laid down in Article 16(3). This guidance document focuses on activities performed by notified bodies and provides clarification on the QMS they are expected to assess. This QMS should include procedures, e.g., which ensure that the translation of information supplied with the device is accurate and up to date. These procedures should ensure that the activities are performed by means and under conditions that preserve the original condition of the device. And they should ensure that the packaging of the repackaged device is not defective, of poor quality or untidy. The guidance outlines the minimum components of the QMS.

MDCG 2021-24 Guidance on classification of medical devices. 

This document provides guidance to manufacturers to help them classify their devices under the MDR before they are placed on the EU market. It clarifies several basic terms and definitions which are useful for the application of the classification principles and rules and provides graphical summaries to explain the medical device classification rules and shows how these rules intersect with each other. The guidance also offers extensive examples of the specific devices that fall into the four groups and into each of the 22 rules.

MDCG 2019-6 Rev 3 Questions and answers: Requirements relating to notified bodies.

The 3rd revision of MDCG 2019-6 which addresses the obligations of notified bodies under the MDR / IVDR clarifies the extent to which notified bodies may offer pre-certification services to their clients in question I.6. Pre-certification services are not allowed before an application is lodged by the manufacturer and therefore these services must take place under the scope of the application. Every activity carried out once an application has been submitted will be considered part of the conformity assessment activities. Services provided by the notified body that could fall under the definition of conformity assessment activities are not allowed outside of an application as they would be regarded as consultancy (e.g., gap analysis, check of MDR/IVDR readiness, use of mock-up files produced instead of “real” TD assessments). Nevertheless, general training activities that are not client specific and that relate to regulation of devices or to related standards are allowed.

What does this mean to you?

MDCG 2021-22 provides you with an essential definition of what is to be considered “the first certification for that type of device”. If you manufacture a class D device this is detrimental in the decision if an expert panel is to be involved or not in the assessment of the device’s performance evaluation report.

MDCG 2021-23 provides useful advice and insights to importers and distributors that are captured under article 16(2) in terms of what their QMS should look like and how a notified body will assess it.

MDCG 2021-24 is an invaluable guidance if you manufacture a medical device. This guidance will help you determine the correct classification of your device.

MDCG 2019-6 rev 3 further emphasises that notified bodies cannot provide any consultancy to manufacturers.

 

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.


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