In Vitro Diagnostics and Medical Devices

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E-Labeling / eIFU

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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.

Breaking: Qarad Joins the QbD group!

We are proud to announce that Qarad is now a part of the QbD Group. Joining forces with Quality by Design is a big new step in our own 21-year history. By combining forces within the QbD group, we will be able to assist clients in the full ‘from idea to patient’ life cycle even better.

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).

Leading the market with specialist eIFU services

Qarad’s president and principal consultant, Dirk Stynen, explains how the company has become a market leader in the area of eIFU, and provides insights into how it continues to grow and excel.

Donation to Doctors without Borders!
AZG

Qarad recently did a survey to gain more insight in the eIFU awareness that exists in the field. Thanks to the numerous respondents who answered our survey, Qarad is proud to have donated €2.225 to Doctors Without Borders!

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.

What do Notified Bodies expect of your eIFU solution and its implementation?

Implementing an eIFU solution in your company has major implications on your QMS. Notified Bodies will review how you handled the process. This article explainswhat you can expect.

Regulatory focus: Impact of the latest rules for European IVD device manufacturers

Dirk Stynen, Qarad's founder and President, was interviewed about the impact of the new IVDR on the field.

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.

QARAD BV

ISO Certified
ISO 13485 and ISO 27001

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