The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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.
In particular, in addition to the general overview of the applicable regulations, the scope of the guidance covers the aspects related to the pre-assessment and off-site activities.
Introduction
The present document MDCG 2022-13Rev.1 provides guidance for the authorities responsible for notified bodies (referred to as Designating Authorities) and joint assessment teams (JATs) in conducting assessments of conformity assessment bodies (CABs). This document, endorsed by the Medical Device Coordination Group under Article 103 of Regulation (EU) 2017/745, is intended to ensure consistency across Member States regarding the assessment, designation, notification, and re-assessment of CABs and notified bodies (NBs).
Key Objectives
As explained by the MDCG, the primary objectives of this document are to:
- Offer guidance for Designating Authorities and JATs during the assessment of CABs applying for designation as NBs in medical and in vitro diagnostic devices.
- Provide a standardized approach to extending the scope of NB designations.
- Ensure regular re-assessments of NBs to verify ongoing compliance with regulatory requirements.
Legal Framework
Under the general rule, the processes for assessment, designation, and notification are detailed in Articles 38 to 42 of the Medical Devices Regulation (MDR) and Articles 34 to 38 of the In vitro Diagnostic Medical Devices Regulation (IVDR).
Extension of designation scope is governed by Article 46 of the MDR and Article 42 of the IVDR. Re-assessments are mandated by Article 44 (10) of the MDR and Article 40 (10) of the IVDR, requiring re-assessments every five years post-initial notification.
Pre-assessment and Off-site Activities
The scope of the document contains a detailed description of pre-assessment and off-site activities pertaining to the designation of conformity assessment and notified bodies as set under the aforementioned regulations.
CAB’s Application
According to the guidance, CABs must submit their applications using the specified forms:
- MDCG 2021-156 for MDR designation.
- MDCG 2021-167 for IVDR designation.
Applications should include detailed information on the conformity assessment activities and device types, adhering to the codes in Implementing Regulation (EU) 2017/2185. Documentation should be formatted for easy transmission and, where possible, provided in English to facilitate the JAT’s assessment.
Upon receiving an application, the designating authority conducts an initial check for completeness, ensuring all required documents are submitted. This check must be completed within 30 days, and any missing information should be requested within this period.
The designating authority may stop the process if the application remains incomplete after several rounds of correspondence. After verifying completeness, the application is sent to the European Commission’s Directorate-General for Health and Food Safety (DG SANTE).
The application should be in electronic format, following specific guidelines to ensure document accessibility and security. The designating authority reviews the application and supporting documents within an estimated three months.
The review ensures compliance with Annex VII of the MDR or IVDR and other relevant regulations. A preliminary assessment report, preferably in English, is then drafted.
Then, the designating authority submits the preliminary assessment report to DG SANTE, which triggers the appointment of a JAT. The report should include updates or new documents created post-application submission.
Appointment of JAT and Scheduling of On-site Assessment
At the next stage, DG SANTE proposes JAT members based on expertise and availability, typically including two DG SANTE experts and two national experts from different Member States. The JAT’s appointment is formalized once no objections or clarifications are raised by the MDCG members.
DG SANTE coordinates with the designating authority and CAB to schedule the on-site assessment, considering the availability of all parties and ensuring sufficient time for a thorough evaluation.
On-site Assessment
Under the general rule, DG SANTE formally announces the on-site assessment, including its dates and the JAT composition, ideally three months in advance. Interpretation services are arranged if necessary. Relevant application documents are shared with JAT members via the SANTE/F CIRCABC workspace for review before the on-site assessment.
In the course of the assessment process itself, the JAT reviews the application and supporting documents, requesting clarifications if needed. A detailed assessment plan is formulated, assigning specific roles to JAT members based on their expertise.
Furthermore, the JAT coordinator maintains regular communication with the designating authority, organizing teleconferences to discuss assessment findings and finalize the assessment plan.
Any changes to supporting documents post-preliminary assessment must be communicated to the JAT, with clear indications of the modifications. The CAB should present a list of changes at the on-site assessment’s outset.
The MDCG additionally mentions that any issues affecting the on-site assessment, such as changes in JAT composition or scheduling, should be immediately communicated to the designating authority and MDCG, along with proposed risk mitigation measures.
The on-site assessment aims to verify the CAB’s compliance with regulatory requirements comprehensively. Following the assessment, the JAT provides feedback to the designating authority, which informs the CAB of the assessment outcome and any necessary corrective actions.
Conclusion
In summary, the document explains that the MDCG 2022-13Rev.1 is designed to standardize and streamline the processes for assessing, designating, and re-assessing conformity assessment bodies and notified bodies in the EU. This document is intended to enhance the efficiency and reliability of the conformity assessment process in the medical device sector by providing detailed guidance and ensuring consistency across Member States.
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