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Archive for month: February, 2018


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].


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.


Brexit & The Medical Device Industry: Worst Case Scenario

 A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorised Representatives and Notified Bodies.

In Jan 2018 the European Commission published a notice that identified medical device companies, authorised representatives and NBs that will be affected by Brexit. Many of these impacts would be only in a “worst case” scenario for example, if no mutual recognition agreement is reached, which at this point in time is unlikely. Testing this theory are the Brussels negotiators pushing a “no deal” concept. 

Brexit and Authorised Representatives (AR)

British manufactures will need an EU based AR, manufactures placing devices onto the EU market can only do so if the firm is based in the EU or they have an EU AR. Some sources speculate the UK will be treated like a third Country.

Importers and distributors

Following this same vein the UK will therefore no longer be able to be used by third countries as importers for the EU. If the distribution network isn’t evaluated and modified UK distributors will instead be considered importers. UK NBs can’t be used for the EU and new NBs will need to be appointed for your products.

Void CE Certificates 

CE certificates for EU regulations can only be issued by Notified Bodies based within the EU. This means that all certificates issued by UK-based Notified Bodies will become void after 29 March 2019. After that date British Notified Body can no longer issue CE Certificates for the EU.

UK-based manufacturers will need an AR, just like any non-EU manufacturer. They will have to create a distribution network with an AR/importer.

Suggested Effects

Problems with distribution networks effected downstream from UK operators will be an opportunity for EU based organisations.

Smaller UK device companies may have device availability effected.

New non UK based NBs will need to be found.

Possibly those most likely hit are British patients.

They will face the prospect of manufacturers that cannot reach the UK market as easily as they do now. Any-UK based manufacturer may incur additional costs for placing devices on the European market, which will be reflected in their product prices.

Emergo, Jan 2018

If you wish to discuss how Instem can support your company through Brexit please reach out to our team with your needs, [email protected] or +1244857900.

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