News

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...

Seeking Regulatory Affairs Consultants

4/5/2022

We’re hiring!

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.

Joint implementation and preparedness plan for IVD Regulation. MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations

14/2/2022

MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations.

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...