The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
Table of content
The Medical Device Coordination Group (MDCG), the European agency focused on further improvement of the medical device regulatory framework, has published a guidance document dedicated to the designation, re-assessment, and notification of conformity assessment bodies and notified bodies. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, they could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Notification and Publication in NANDO
According to the document, once the procedures for designating a Conformity Assessment Body (CAB) are completed, the designating authority proceeds with the notification to the Commission and other Member States. This notification is carried out using the electronic notification tool within the Commission’s NANDO information system, specifically the notifying authorities notifications module of NANDO-Input.
The notification submitted by the designating authority includes comprehensive information:
- Designating Authority Information: Name and postal address.
- Reference Legislation: Either Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
- CAB Identification: Name, postal address, telephone, email, and website of the CAB.
- Scope of Designation: Tasks and types of devices the CAB is authorized to assess, specifying vertical and horizontal technical competences, product family, intended use, and product range using codes from the Commission Implementing Regulation (EU) 2017/2185. The applicable conformity assessment procedures and modules, related annexes, and any conditions or restrictions associated with the designation are also included.
- Generated Documentation: The system generates a PDF format “Notification of a Body in the framework of a technical harmonization directive”, including the four-digit number assigned to the CAB (NB xxxx), the notification date, and any subsequent updates.
It is explicitly stated that when submitting a new notification, the designating authority must also enter the date for the first reassessment, recommended to be approximately five years (+1 month) after the notification.
The notification is accompanied by several supporting documents:
- Final Assessment Report: Provided by the designating authority.
- Joint Assessment Team (JAT) Final Opinion: As per prior assessment steps.
- Medical Device Coordination Group (MDCG) Recommendation: On the draft designation.
- Final Decision on Designation: By the designating authority.
Additionally, feedback on the MDCG recommendation and information about monitoring activities are included, detailing how the CAB will be regularly monitored to ensure continued compliance with applicable requirements. Monitoring includes annual surveillance assessments, on-site assessments, assessments of subsidiaries and subcontractors, and observed audits.
The designating authority will also review the CAB’s assessment of the manufacturer’s technical documentation on a sampling basis.
Objection Period
Upon receiving and validating the notification, the Commission’s NANDO system sends an email to the Member States’ authorities. This preliminary notification informs them of the new notification and the CAB’s name and number, allowing a 28-calendar-day period for objections.
If no objections are raised, the notification is definitively validated and published by the Commission within 42 calendar days. Objections can be raised by the Member States or the Commission, with the MDCG providing its opinion on the objection.
The notifying Member State must respond in writing to any objections, justifying their decision. If the MDCG accepts the notification despite objections or if the notifying Member State confirms its decision, the Commission will publish the notification in NANDO within 14 calendar days.
Publication and Validity
Once published in NANDO, the system notifies Member States’ authorities via email, providing a link to the full notification details. The CAB’s designation becomes valid the day after publication, enabling the CAB to perform notified body activities within the designated scope.
Assessments for Scope Extension
Another important aspect described in the document relates to the extension of the scope of designation. The process for extending the scope of a CAB’s designation follows Articles 46 of the MDR and 42 of the IVDR.
The Member State specifies the notified body’s scope of designation and any conditions associated with it. This extension process generally mirrors the initial designation assessment but is adjusted based on the impact of the application for the extension.
The initial steps for pre-assessment and off-site activities are similar to those outlined in the designation assessment. Given that the CAB’s compliance has been previously assessed, the application content is limited to information relevant to the scope extension.
The subsequent appointment of the JAT and scheduling of the on-site assessment are adjusted based on the specific case. Factors influencing adjustments include the extent of the scope extension, the number of new codes, and the qualifications to be reviewed.
Typically, on-site assessments for scope extensions require about 16 hours, but this may vary. Post on-site assessment procedures and timelines are proportionate to the scope extension application.
The decision on granting the extension follows the established procedures, ensuring the initial notification date remains the reference for reassessment dates, unaffected by scope extensions or other designation changes. The authority also mentions that certain changes, such as lifting conditions or adding conformity assessment routes within existing codes, do not qualify as scope extensions and follow simpler procedures without requiring a joint assessment process.
These changes are immediately notified and published in NANDO.
Conclusion
In summary, the document provides additional clarifications regarding the procedures associated with the designation of notified bodies, including the relevant notifications, as well as the changes to the initial scope of designation.
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