Medical device CE marking

Current status MDR / IVDR Notified Bodies

2022-11

At the moment there are 34 notified bodies designated to perform audits according the MDR:

The current status of NBs under the IVDR is 7:

Source: NANDO database

MDCG issues new revision of MDCG 2021-22 and MDCG 2019-6

2022-10

The MDCG issued a new revision of the MDCG 2021-22 and the MDCG 2019-6:

MDCG 2021-22 Rev.1 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 Regulation (EU) 2017/74

and

MDCG 2019-6 Rev4 Questions and answers: Requirements relating to notified bodies

The documents can be downloaded in our library (click on the MDCG number)

Source: European Commission

MDCG 2022-15 issued on Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR

2022-09

This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system.

The document applies to notified bodies that have lawfully issued certificates under the IVDD, regardless of whether or not those notified bodies have applied for designation or are designated under the IVDR (see MDCG 2019-10 rev.18) as long as the respective authority responsible for notified bodies has the right to and does monitor the notified body’s activities under Article 110(3) IVDR.

The document can be downloaded in our library

Source: European Commission

New European manual on borderline and classification for medical devices and IVDs

2022-09

The European Commission has published an 18-page manual on borderline and classification for medical devices under the Medical Devices Regulation and IVD Regulation. This version 1 is a working document, and is described as a support tool and not a legal document, also not one that represents the opinions of the commission. The views represent agreements reached by the competent authorities of the member state members of the Borderline and Classification Working Group (BCWG), this is a subgroup of the Medical Device Coordination Group (MDCG).

The document can be downloaded in our library

Source: European Commission

MDCG 2022-14 Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs

2022-08

On August 26, 2022, the MDCG endorsed MDCG 2022-14 Position Paper with a list of actions to increase the capacity of notified bodies and the preparedness of manufacturers, in an effort to facilitate the transition to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The document can be downloaded in our library

Source: European Commission

MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies

2022-08

This document aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams when conducting 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 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 States, regarding the assessment, designation, notification and re-assessment of CABs and NBs.

The document can be downloaded in our library

Source: European Commission

Published: MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (IVDR)

2022-7

On July 13 the European Commission published MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence
of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the
exchange of information until Eudamed becomes fully functional.

The document can be downloaded in our library

Source: European Commission

Blue Guide on Implementation of EU product rules 2022 published

2022-06

On June 29, 2022, the European Commission published the ‘Blue Guide on the implementation of the product rules 2022’. The Guide is meant for a better understanding of EU product rules and facilitation of their uniform application across sectors throughout the Single Market.

The product rules are aligned with the New Legislative Framework, which covers for instance toys, measuring instruments, radio equipment, low voltage electrical equipment, medical devices, fertilising products. The Blue Guide also provides explanations and advice regarding the European conformity assessment system, the accreditation of laboratories, the CE marking, and market surveillance.

The Blue Guide is a non-binding instrument and it was published in 2000. It has been subsequently updated twice, in 2014 and 2016. The current revision is a substantial update and takes into account developments that have come up since 2016, for example related to the Market Surveillance Regulation (EU) 2019/1020. It also elaborates on specific features such as distance sales, making products available on the market subject to physical modifications or software updates and the assessment of conformity assessment bodies. The guide is available in Irish for the first time.

The guide can be downloaded in our library

Source: European Commission

MedTech published recommendations on the use of guidance documents

2022-06

This Position Paper concerns documents that assist stakeholders to implement the Medical Devices Regulation, 2017/745 (“MDR”) and the In Vitro Medical Devices Regulation, 2017/746 (“IVDR”). In order to assure market availability of safe and performing medical devices, this Position Paper lays out an industry view on expectations for the use and pragmatic timing of application of such documents.

The document can be downloaded in our library

Source: MedTech Europe

Notice to manufacturers to ensure timely compliance with MDR requirements

2022-06

The European Medical Device Coordination Group has issued a position paper concerning the transition to the MDR.

Many MDD certificates will expire in 2023 and 2024. In order to be in time for MDR certification, it is necessary to submit the MDR technical documentation well in time before the MDD certificate expires. This also applies to devices which are up-classified and require a NB-assessment under the MDR. The grace-period for these devices ends on the 26th of May 2024. Discuss the procedure and timeline with your Notified Body. Currently there are 30 Notified Bodies accredited: NANDO database

The document can be downloaded in our library

Source: European Commission