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Quality Management Workshop Codex4SMES

30/5/2022

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Economic Operators Workshop Codex4SMES

30/5/2022

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Workshop for SMEs

30/5/2022

The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different work...

Welcoming IVDR

26/5/2022

Med-Di-Dia Welcomes In-Vitro Diagnostic Regulations #IVDR #IVDRReady

Summary of safety and performance Template – MDCG 2022-9

25/5/2022

MCDG Published a template for summarising the safety and performance requirements.

Questions and Answers on the Unique Device Identification system

23/5/2022

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG Guidance 2022-8

20/5/2022

MDCG Publishes Guidance on Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Direc...

MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

4/5/2022

In order to benefit from the transition periods provided in Article 110(3) IVDR, devices may not undergo any significant change in the design or intended purpose after the date of application of the I...

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

26/4/2022

This report highlights the updates from the implementation of Medical Device Regulations – MDR and upcoming In-Vitro Diagnostic Regulations – IVDR.

IVDR Celebration Week

13/4/2022

series of weeklong fireside chats to celebrate the incoming IVD Regulations in the European Union.

MDCG published A Summary of safety and clinical performance

28/3/2022

This summary of safety and clinical performance is a guide for manufacturers and notified bodies.

Regulatory Funding Opportunity for Health Tech SMEs

1/3/2022

If you are an SME working in HealthTech, you can apply for up to £30,000 of funding for use with regulatory affairs providers, to help you navigate regulatory pathways.

Updates for SaMD using Blockchain

10/2/2022

EU Blockchain Observatory and Forum introduces a thematic report on Blockchain Applications in the healthcare sector.

Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

27/1/2022

MDCG 2022-2 releases Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs).

IVDR Regulation Amendment Update

25/1/2022

In response to the proposal sent on 14.10.2021 with regards to a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certa...

MDCG advice for non EU/EEA SARS-CoV-2 infection IVD Manufacturers.

13/1/2022

MDCG 2022-1 (January 2022) - Addressees IVD manufacturers with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection

Harmonised standards updated for MDR IVDR

8/1/2022

The new year has started with new decisions and publications.

Medical Technologies and Advancements

27/10/2021

What does Digitalisation bring to MedTech?

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