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Archive for month: April, 2018

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GUDID v2.3

The FDA have announced their plan for the latest version of GUDID, version 2.3 will see some specific data made available to the public. The latest version will be available from May 2018 and the FDA will make the data publically available from June 2018.

The FDA have stated

The FDA plans to make public the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI) record via AccessGUDID and OpenFDA. The premarket numbers provide an essential link to information about device safety and effectiveness; making them public as part of the GUDID DI record information is crucial to achieving the public health benefits of UDI.

FDA GUDID Enhancements and Fixes

Following these changes the FDA goes on to strongly encourage labellers to review their confidentiality agreements, if they wish they can then assign confidentiality designations to proprietary names for existing listings.

For support with your FDA device registrations, FDA UDI compliancy and regulatory tracking reach out to our expert team via +44 1785 825653 or email [email protected]

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EU and UK Determine MDR Timeline for BREXIT

This April sees an update of the MDR ‘Withdrawel Agreement’, the transition period has been extended by an additional 21 months to December 2020. This will enable the UK to take on the MDR and IVDR.

The transition period begins in March 2019 and will end Dec 2020 giving the UK an additional 21 months to prepare to take on MDR & IVDR. The draft agreement is to go through the British Parliament and will then need to be accepted by the European Member States.

The agreement refers to a transition period but what this entails is not clear. What it does suggest is that the British and European negotiators need to decide clear rules so that as the UK adapts appropriately to its new role under Brexit.

The timeline for adoption of the MDR in the EU does not tie in with the Brexit exit day but when the MDR becomes applicable in EU legislation this will also apply in UK law.

This would result in the following situation:

The UK would become a non-EU market, not recognizing the EU Court of Justice, but British industry would manufacture medical devices and IVDs in compliance with European requirements.

The impact on the medical devices in the UK is undetermined until more details emerge. It has been suggested the ideal outcome is that the UK companies will except the authority of the EU without any deviations or addition of their own interpretations. Whether this is what Brexit supporters envisioned is not clear and more will emerge as the agreement progresses.

For support transitioning to the EU MDR & IVDR reach out to Instem via +44 1785 825653 or email [email protected]

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