Medical device CE marking

Category: Uncategorized

MDCG 2021-08 Clinical investigation application/notification documents

2021-05

On May 21, the MDCG has issued a guidance document, MDCG 2021-08 Clinical investigation application/notification documents, collating a series of clinical investigation application/notification documents to support relevant procedures under the MDR.
These documents include:
– Clinical investigation application/notification form under the MDR (with the same data fields to the Eudamed system in development);
– Addendum to the clinical investigation application/notification form for: additional investigational device(s) (section 3); additional comparator device(s) (section 4); and additional investigation site(s) (section 5);
– Clinical investigation supporting documents ̶ appendix of documents to attach; and
– Checklist of general safety and performance requirements, standards, common specifications and scientific advice.

The document can be downloaded in our library

Source: European Commission

Team-NB members adopted a Position Paper with considerations on conformity assessment for class D devices

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

The UDI Helpdesk is live

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

MDCG 2021-1 Guidance on administrative practices until EUDAMED is fully functional

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

European Commission publishes Factsheet for Class I Medical Devices

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