Progressive roll-out of IVDR proposed!

the European Commission proposed a progressive roll-out of the IVDR to prevent disruption in the supply of IVD products to the market. The proposal does not change any requirements of the IVDR in substance but only changes the transitional provisions stipulated in Article 110, to allow a progressive rollout.

EUDAMED UDI/Devices and NBs & Certificates modules are open!

The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module), except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities, are available since 4th October 2021. The remaining modules as well as the mechanism for scrutiny and the CECP in the Certificates and Notified Bodies module, will be released when EUDAMED is fully functional.

New MDCG Guidance documents released!

These new documents provide clarification on “first certification for that type of device” and corresponding procedures to be followed by NBs, in context of the consultation of the expert panel referred to in Article 48(6) of the IVDR (MDCG 2021-22), provide direction for NBs, distributors and importers on certification activities in accordance with Article 16(4) of the MDR and IVDR (MDCG 2021-23) and provide guidance on classification of medical devices (MDCG 2021-24). A third revision of the MDCG 2019-6 addressing “Questions and answers: Requirements relating to notified bodies” was also released.

EN ISO 13485:2016+A11:2021 published!

Early September 2021, the amendment, EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC. This amendment features new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the ISO 13485:2016 standard.

Another wave of MDCG Guidance documents released!

New guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents provide explanatory notes on the IVDR codes, introduce four forms to be used by conformity assessment bodies when applying for designation under the MDR or IVDR, provide guidance on the integration of UDI within an organisation’s QMS, provide instructions for generating CIV-ID for MDR Clinical Investigations and provide guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.

First MDR and IVDR harmonised standards published

COMMISSION IMPLEMENTING DECISION (EU) 2021/1182 and COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 were published in the Official Journal of the European Union (OJEU).

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).

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?

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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