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Brexit – Time to have an EU Authorised Representative (EC Rep) in place


Brexit – Time to have an EU Authorised Representative (EC Rep) in place

Brexit making headlines again - What is the impact for Medtech companies market access to the EU?


With Brexit making headlines again due the UK not extending the transition time with the EU, UK manufacturers face a tense time.

That was the week that was!


Wow what a week it has been for Med-Di-Dia: we had the official launch of our company on Monday 16th September - a key milestone.

Free Workshop in Galway: EU Medical Device Regulation – will your company be compliant in 8 months?


Dr Kieran Connole, Regulatory Specialist at Med-Di-Dia, will speak about the reality of achieving compliance with the EU MDR. Free tickets via Eventbrite.

Impact of Brexit on UK and EU based Medical Device Manufacturers


It is looking more likely that a No-Deal Brexit scenario is coming as of 31st October 2019. With that, Medical Device manufacturers are further caught in the crossfire while already being pinned down ...

Brexit seems to be getting closer to being a reality?


With a new UK Prime Minister, there's been an increase in the number of notifications about what will happen in the event of the UK leaving the EU without an agreement. One of the first notifica...

EU Commission needs your feedback - single-use medical devices


The European Commission (EC) has recently published the safety and performance requirements for reprocessing of single-use devices under the new medical devices regulation (MDR). This is your chance t...

The Domino Effect?


The last few months have not been a good time for EU Notified Bodies (NBs) and the impact on the MedTech Industry is even worse.

Another EU Notified Body leaves the ‘pond’


There seems to be a rapidly dwindling number of EU Notified Bodies (NBs) so that what was once quite a crowded pond is now looking more like a sea with very little fish in it! With fewer NBs there is...

Europe vs. US - is the tide turning??


For a while now there have been ‘mutterings’ that the new EU regulations will make the European MedTech sector less competitive and that business will be lost to the US. For many years, E...

Second Notified Body is designated and notified under the new EU Medical Device Regulation


Congratulations to TÜV SÜD Product Service GmbH Zertifizierstellen in Germany which has become the second Notified Body to be designated and notified under the EU Medical Devices Regulation ...

The Clock is Ticking …


Everyone should know by now that the MedTech Sector is in a transition period to achieve compliance with the new EU Medical Device and IVD regulations.  Full enforcement of the EU Medical Devices...

New website for Med-Di-Dia


We hope you will enjoy exploring the new Med-Di-Dia website.  This website is similar to a Curriculum Vitae (or “resumé” as our US colleagues say!).  In other words, it&rs...

New home for Med-Di-Dia


We’re proud to be located within the Galway Technology Centre on the Mervue Business Park in Galway.  This is a great place for launching Med-Di-Dia onto the Irish MedTech scene. 

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