New MDCG Guidance documents released!

The new guidances contain information on status of the Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices, implant cards, EMDN and a Q&A on obligations and related rules for the registration in EUDAMED of certain IVDR/MDR actors.

ISO 15223-1: 2021 Published!

This new standard includes newly validated symbols and defined terms from older guidance documents.

New MDCG Guidances released!

New guidance documents were released to offer guidance on standardisation for medical devices, Q&A regarding clinical investigation under MDR , provide a notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 IVDs and clarifies clinical investigation application/notification documents.

European Medical Device Nomenclature (EMDN) + UDI Helpdesk!

May 4th, 2021, the first version of the European Medical Device Nomenclature (EMDN) was released by the European Commission and on May 18th, 2021 the UDI Helpdesk was launched.

Swiss Third Country Status!

A new Mutual Recognition Agreement between Switzerland end the European Union including MDR/IVDR remains outstanding. In addition, the ongoing negotiations between Switzerland and the EU for a transitional solution for MDD products have not yet been concluded, and have not yet resulted in any agreement. Therefore, all Swiss manufacturers and distributors of medical devices must be aware that as of 26 May 2021 they will have to comply with the requirements of a third country for all medical devices (MDR and MDD).

Updated AER codes published by IMDRF!

The International Medical Device Regulators Forum (IMDRF) published an updated version of the Adverse Event Reporting (AER) codes and terms on 2 March 2021. These codes/terms are to be used in the EU Vigilance reporting.

New MDCG Guidance documents released!

The new MDCG documents offer guidance on state of the art of COVID-19 rapid antibody tests, provide Q&A on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices and clarify the application of transitional provisions for certification of class D IVDs according to IVD-R 2017/746.

Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?

An eIFU solution has to comply with many requirements. But what about the application of Design Control and Life Cycle management? Shall your eIFU solution comply to the strict rules of EN62304?

Management of Legacy Devices in EUDAMED!

On 15 February 2021, the European Commission published a document explaining how and when Legacy Devices will be identified in the new EUDAMED database and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned.

MDCG 2021-1 What to do while EUDAMED is being built!

On 26 February 2021, the European Commission released MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.

UDI FAQ

The European Commission has published a Q&A document explaining how the Unique Device Identification (UDI) system will work under the EU medical devices Regulations 2017/745 and 2017/746.

Medica - November 15-18, 2021
Medica

Visit our booth at Medica 2021 or schedule a meeting upfront with one of our experts! You can find us in Düsseldorf between November 15 and 18, 2021.

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