Med-Di-Dia

MENU menu

Knowledge Center

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?

Pandemics - Future and Present

25/10/2021

Pandemic - Present and Future

Classification of Medical Devices.

12/10/2021

October brings in clarification on the classification of different medical devices under the EU MDR.

Future of Medical Device Regulations

5/10/2021

Regulations in the United Kingdom

Friday Weekly Run Through 01 October

1/10/2021

Enjoy your Friday with a MedTech Snippet

Clouding Medical Industry!

28/9/2021

The medical industry sees a big boom in Cloud Investments…

75% IVDs may Lack IVDR Certification!

21/9/2021

MedTech Europe warns IVD manufacturers might not be able to certify their product before the deadline.

Friday Weekly Run Through

17/9/2021

Presenting Med-Di-Dia Friday Weekly Run Through for 17th September 2021 All things MedTech and Regulatory

Software Freedom Day

15/9/2021

Med-Di-Dia Celebrates Software Freedom Day!

Global Collaboration - Ireland and India

14/9/2021

A step towards Global Collaboration!

8 Challenges Affecting Medical Devices

7/9/2021

Top challenges affecting Medical Device Manufacturers.

  Page 4 of 7