Medical device CE marking

MDCG 2021-10 Status Appendixes E-I IMDRF N48

2021-06

On June 4 the MDCG issued MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.

For ease of readability, this document intends to provide clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR. The examples provided within the Appendixes are for informative purposes and should not be interpreted as the sole manner for complying with UDI obligations. It is recommended that these documents are always read in conjunction with the MDR and the IVDR.

The document can be downloaded in our library

Source: European Commission

Status of the EU-Switzerland Mutual Recognition Agreement (MRA)

2021-05

The European Union and Switzerland have not been able to update the existing MRA to cover the MDR. This means that Switzerland will become a “third country” as regards to medical devices (EU perspective). Devices on the EU market may no longer move freely to the Swiss market. Devices which will be put on the Swiss market have to comply with the Medical Device Ordinance (MedDO).

The European Commission has issued this guidance, it can be downloaded in our library
The Swiss Authorities have published this guidance: Link

Update of the EU-Turkey Customs Union for medical devices

2021-05

The EU-Turkey Customs Union for medical devices, including the signing of an Administrative Arrangement for the transfer of personal data between the European Commission and the Turkish Medicines and Medical Devices Agency, and the Customs Union Joint Committee Statement confirming Turkey’s alignment with the EU Medical Devices Regulation 2017/745 has been concluded.

This confirms the continued integration of Turkey to the EU market on medical devices and the facilitation of trade. As previously mentioned, a similar alignment to enable the continuation of EU-Turkey customs union for in-vitro diagnostic devices will follow.

The document can be downloaded in our library

Source: European Commission

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