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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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Combination Products: New PMSR FDA Deadline

FDA announces new compliance deadlines for the combination product post-market safety reporting (PMSR).

In order to allow combination product applicants more time to get their procedures and reporting in order the FDA have pushed the PMSR compliance deadlines to 2019 and 2020.

The PMSR rules were finalised in 2016 but the FDA have chosen to push this to July 2019 for combination products using the FAERS & eMDR reporting systems. In addition by Jan 2020 for combination applicants  using the VAERS reporting system.

The FDA’s DRAFT guidance for this can be found here.

For regulatory management and tracking of your combination products or advice from our team reach out to Instem via +44 1785 825653 or email [email protected].

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Switzerland: MedDO to MDR

The Swiss Federal Office of Public Health (FOPH) has announced that their current medical device standard Medical Devices Ordinance (MedDO) will undergo revisions in order to reflect the EU’s adoption of the MDR and IVDR. Although Switzerland isn’t part of the European Union it bases its regulations around the EU rules in order to maintain access to the EU market.

The enforcement of the new EU MDR rules is thought to be a staged approach but ultimately tie in with the EU times lines, therefore this will come into force in Switzerland during 2020.

If you have any concerns regarding managing changing standards on a global scale the Instem team are always here to help. You can call us on +44 1785 825653 or email [email protected].

 

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Could the EUDAMED set the global standard?

With the implementation of UDI in the EU following the roll out of the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), the European Database for Medical Devices (EUDAMED) has been created in anticipation. It has now been suggested that this database will be extended and set the global data exchange standard. 

Currently when accessing EUDAMED European Authorities have full access to the data while those outside only have public or limited access. The European Commission is considering extending the access to boost sharing of the device safety information with the suggestion that this can set the standard for global data exchange in the industry.

This extended access will be rolled out, the European Commission is thought likely to choose those already taking part in the NCAR exchange programme. The data exchange would be an extension to the NCAR system.

This seems a very ambitious project and we imagine it will take some time to coordinate. We suspect that it will require other UDI systems to become compatible with EUDAMED and that they will be involved in its further development.

If you would like some assistance with managing your medical devices and their UDI data please reach out to our experts here at Instem. This can be done via our main contact number +44 1785 825653 or email us on [email protected].

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Latest MDR & IVDR Progress

Where are we now

25th May 2016: MDR & IVDR final agreement was reached

7th March 2017: Final adoption from EU council

5th April 2017: Final adoption from EU parliment

5th May 2017: Official publication

25th May 2017: MDR & IVDR now in force

26th Nov 2017: NBs apply for designation

26th May 2020: Full application for MDR from now on

26th May 2022: Full application for IVDRfrom now on

 

Transition Timeline For MDR & IVDR

For assistance with your EU UDI compliance or managing your medical device data and registrations reach out to our expert team at [email protected] or +44 (0) 1244857901.

Contact us for a demo now!