scope:

Introduction and scope

This document¹ aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting:

i. assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices, and

ii. re-assessments of NBs.

Furthermore, this guide is intended to bring consistency and to align the working practices of the different designating authorities in the Member States², regarding the assessment, designation, notification and re-assessment of CABs and NBs.

The processes for assessment, designation and notification are established by Articles 38 to 42 of Regulation (EU) 2017/745³ (hereafter, the Medical Devices Regulation - MDR) and Articles 34 to 38 of Regulation (EU) 2017/746⁴ (hereafter, the in vitro Diagnostic Medical Devices Regulation - IVDR).

The processes for re-assessment are established by Article 44 (10) of the MDR and Article 40 (10) of the IVDR, whereby it is stated that three years after notification of a notified body, and again every fourth year thereafter⁵, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII to MDR and IVDR shall be conducted by the designating authorities and a joint assessment team.

In terms of scope, this guide focuses on the designation of CABs and subsequent reassessments of NBs under the MDR and/or the IVDR. A subsequent revision will address the processes for changes to designations and notifications (Article 46 MDR and Article 42 IVDR).

Note: In the MDCG, the Commission and Member States have identified notified body capacity as a critical issue and are committed to progress CAB's applications for designation and notification without undue delay.

¹ This document was endorsed by MDCG and published as NBOG BPG 2017-1 in its first version in February 2018. Based on experience gained in the context of the joint assessment process, the document has been updated, adding also clarification on the re-assessment process and notification procedure and its revision published as MDCG document.

² References made to "Member States" in this guide should be understood as referring to Member States, EEA and EFTA countries and other countries where a relevant agreement covering mutual recognition of designation of CABs and NBs.

³ Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

⁴ Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

⁵ According to Art. 11(11) MDR and 40(11) IVDR, the Commission is empowered to adopt delegated acts modifying the frequency at which the complete re-assessments are to be carried out.