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NewsUK

Advantages of conducting business in the UK. Possible under the MDR?

There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medi...

MDSS September 27, 2023
MDRNews

Flowchart for determining eligibility under the extended MDR transitional period for Devices

The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional per...

MDSS September 6, 2023
NewsSwitzerland

Swiss Database on Medical Devices – swissdamed!

Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully...

MDSS August 24, 2023
MDRNewsUK

Important Announcement: CE-Marking Extensions and Medical Devices in the UK

The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...

MDSS August 2, 2023
MDRNews

Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers

Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufac...

MDSS
MDRNewsUK

Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update

UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No...

MDSS June 20, 2023
NewsUK

New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! Subject to Parliamentary approval, the UK pl...

MDSS May 2, 2023
NewsUK

Implementation of Future Regulations for Medical Devices in the UK

The UK government is planning a substantial reform of the current regulatory framework for medical devices in the country. In response to the 2021 con...

MDSS April 28, 2023
NewsUK

UK Guidance update with MORE Submissions & Production API

The UK government has recently updated its guidance for CE marked medical devices in Great Britain with new information on MORE Submissions and Produc...

MDSS April 26, 2023
NewsUK

Crafting an Intended Purpose for Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) As a Software Medical Device (SaMD) manufacturer, you know that regulatory compliance is key to market success. De...

MDSS April 24, 2023
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Recent Posts

  • Advantages of conducting business in the UK. Possible under the MDR?
  • Flowchart for determining eligibility under the extended MDR transitional period for Devices
  • Swiss Database on Medical Devices – swissdamed!
  • Important Announcement: CE-Marking Extensions and Medical Devices in the UK
  • Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers

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