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EU AI Act and Digital Health

EU AI Act and Digital Health

Would there a major impact on Digital Health?

8.5.2024

How to assign Master UDI-DIs to contact lenses: A new regulation update

How to assign Master UDI-DIs to contact lenses: A new regulation update

The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.

26.3.2024

eSTAR and Pre Market Approval

eSTAR and Pre Market Approval

On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.

29.2.2024

eSTAR: A New Way to Submit 510(k) Submissions Electronically

eSTAR: A New Way to Submit 510(k) Submissions Electronically

If you are a medical device manufacturer who plans to submit a premarket notification (510(k)) to the FDA, you may want to know about eSTAR

21.2.2024

AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.

1.2.2024

CE Mark extension is NOT Automatic

CE Mark extension is NOT Automatic

The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..

29.1.2024

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Prioritise patient safety with these steps!

27.10.2023

Pre-market Submissions for Device Software Functions

Pre-market Submissions for Device Software Functions

MedTech is not just about a medical device with capabilities!

11.8.2023

IVDR Documentation Submission – Best Practices

IVDR Documentation Submission – Best Practices

IVDR Documentation Submission Best Practice Guidelines

4.8.2023