2021-05

Due to the lack of required regulatory infrastructure, the conformity assessments for class D IVD devices can not currently be completed under the IVD Regulation. Following the publication of MDCG 2021-4 ‘Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 in April 2021’, Notified Bodies suggest an approach to performing conformity assessments of class D devices, in the absence of EU Reference Laboratories and consideration of the delay to the IVD Expert Panel becoming operational based on the issued guidance. Some outstanding questions remain and need to be urgently addressed by the Commission.

The document can be downloaded in our library

Source: Team-NB

2021-05

The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.

This helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices. This helpdesk will also provide support as regards the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to the manufacturers and other natural or legal persons required by the MDR and IVDR to use it.

Source: European Commission

2021-05

The EU’s MDCG issued  this notice on May 18 to manufacturers and authorised representatives as a statement telling manufacturers of their legal responsibilities under the current IVD Directive.

The document can be downloaded in our library.

Source: European Commission

2021-05

The MDCG issued guidance 2021-1 in February 2021 and the document was updated with Rev 1. on May 4, 2021. The document provides guidance to Member States and other relevant parties on the application of certain MDR 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

2021-04

On April 28, the European Commission published a useful three-page Factsheet for Class I Medical Devices. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 (MDR). For further information, consult MDCG 2019-15 rev.1.

The document can be downloaded in our library

Source: European Commission

2021-04

The MDCG issued revision 4 of the guidance MDCG 2018-1 on BASIC UDI and changes to UDI-DI.

The document can be downloaded in our library

Source: European Commision

2021-02

The European Commission issued a Q&A on in vitro diagnostic medical device conformity
assessment and performance in the context of COVID-19.

The document can be found in our library.

Source: European Commission

2021-02

The European Commission has published a document explaining how and when legacy devices will be identified in the new Eudamed medical device database. Legacy devices are products that have been CE marked in the context of the current medical device directives but not under the new Medical Device Regulation, nor the IVD Regulation.

The Management of Legacy Devices is a technical document, the majority of which consists of flowcharts and other tables, which explains how the different Unique Device Identifiers (UDIs) will be generated/assigned for legacy devices as part of registration.

The document can be downloaded in our library.

Source: European Commission

2021-02

MHRA has published an updated guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark.

The document can be downloaded in our library.

Source: MHRA

 

2021-02

On February 4, the EC, EMA and HMA issued a new version (v4) of the Guidance on the management of clinical trials during the COVID-19 (Coronovirus) pandemic.

Key changes from v3 (April 27, 2020): remote source data verification.

The document can be downloaded in our library

Source: European Commission