Medical device CE marking

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

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

Obligations for authorised representatives, importers and distributors

2022-05

The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.

The information sheet can be downloaded in our library

Source: Swissmedic

MDCG published a Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

2022-05

This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It was developed by clinical trial experts from Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the Medical Device Coordination Group (MDCG). It has been adopted by CTFG, the Clinical Trials Expert Group of the European Commission and endorsed by the MDCG.

The need for interoperability of databases for clinical trials with medicinal products and medical devices is laid down in the new Regulations, however, no further details on the interface of IVDR and CTR are in the legislation, e.g. the requirements for assays used in the context of clinical trials.

Assays used in clinical trials may range from CE marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. The need to clarify requirements for these assays lead to the Q&A and the concept of the “medical purpose of an assay in a clinical trial” as a specific setting.

The document can be downloaded from our library

Source: European Commission

Commission publishes information on the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

2022-05

Until now, Switzerland has been participating in the European Union internal market for in vitro diagnostic medical devices through the medical devices chapter of the EU-Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA has provided for recognition of conformity assessment certificates between the European Union and Switzerland based on equivalence of Directive 98/79/EC on in vitro diagnostic medical devices and the corresponding Swiss legislation. This has facilitated seamless trade of in vitro diagnostic medical devices between the parties.

The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices has become applicable on 26 May 2022, replacing Directive 98/79/EC. In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022.

As a result, the trade facilitating effects of the MRA for in vitro diagnostic medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorized representative and the alignment of technical regulations, cease to apply as of that date.

The document can be downloaded from our library

Source: European Commission

3 New MDCG documents published

2022-05

On May 20, 2022, the MDCG published 3 new documents:

  • MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
    This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
  • MDCG 2022-8 – Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
    Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3), in terms of scope and timing. Following the approach set out in the report of the MDCG ad hoc task-force on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) published as MDCG 2021-25 , the present document provides guidance as regards the applicability of IVDR requirements to ‘legacy devices’ and ‘old’ devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to ‘legacy devices’.
  • MDCG 2022-9 – Summary of safety and performance Template
    Section 1 – SSP Template for devices not intended for self-testing
    Section 2 – SSP Template for self-testing devices

Source: European Commission

MDCG 2022-6 published on Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

2022-05

On May 4, 2022, the MDCG published the 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.

The document can be downloaded in our library

Source: European Commission

MDCG 2022-5 published on (MDR) borderline products: medical devices and medicinal products

2022-04

On April 26, 2022 the MDCG published the MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

The document can be downloaded in our library

Source: European Commission