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Tag: IVDR

Posted on 20 June 202222 June 2022

ITALY: approved draft of the national decree adjusting to MDR/IVDR

During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national …

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Posted on 30 May 202213 June 2022

EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace

MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks …

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Posted on 28 March 202228 March 2022

MDCG: last guidelines on class D IVDs and legacy devices

Last month, the Medical Device Coordination Group (MDCG) published two important guidelines. MDCG 2022-3 “Verification of manufactured class D IVDs …

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Posted on 24 February 20221 March 2022

EUROPE: MDCG 2022-2 on clinical evidence for IVD devices published

The Medical Device Coordination Group published the new guidance MDCG 2022-2 “Guidance on general principles of clinical evidence for In …

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Posted on 19 January 202220 January 2022

EU: new standards harmonised for MDR and IVDR regulations

In the first week of January 2022, Commission Implementing Decision (EU) 2022/6 concerning new harmonised standards MDR (EU) 2017/745, and …

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Posted on 19 January 202224 February 2022

EU: progressive roll-out of the IVDR (EU) 2017/746 adopted by the EU

UPDATE OF 25 JANUARY 2022 OFFICIAL! PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN UNION REGULATION (EU) 2022/112 AMENDING REGULATION IVDR …

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Posted on 20 December 202120 December 2021

EUROPE: IVDR Implementation Plan updated

In October 2021, the Medical Device Coordination Group (MDCG) published the “Joint implementation and preparedness Plan for Regulation on in …

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Posted on 29 November 202124 February 2022

EUROPE: a proposal to extend the IVDR (EU) 2017/746 Regulation

UPDATE OF 25 JANUARY 2022 OFFICIAL PROGRESSIVE ROLL-OUT OF REGULATION IVDR (EU) 2017/746 FOR CERTAIN IVD DEVICES.REGULATION (EU) 2022/112 OF THE …

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IVDR Emergency Kit

IVDR Emergency Kit: the fastest solution to respond to the main obligations of the IVDR (EU) 2017/746. Experts Thema projected a …

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Acronyms and Definitions

The most commonly used acronyms in the field of Medical Devices and In Vitro Diagnostic Medical Devices (IVD) (in alphabetical …

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+ Why is the CE marking required

  • How will the IVDR 2017/746 affect the Quality System Management?

  • What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic medical devices?

  • What are the main changes compared to the previous Directive 98/79/EC?

  • When will the IVDR 2017/746 enter into force?

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+ What are the GMP requirements

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+ How to register radiation emitting medical devices with the CDRH

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+ MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”?

  • What is the “period of grace” and how can I take advantage of it?

  • What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?

  • What are the MDR requirements for post-market surveillance, market surveillance and vigilance?

  • What is the “post-market surveillance system”?

  • How can I continue to sell my devices after the full implementation of MDR?

+ IVDR (EU) 2017/746

  • What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

  • When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?

  • How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?

  • What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • What is the “sell off” provision?

  • Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

+ Swiss-Exit: requirements to market Medical Devices in Switzerland

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