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A dip in Asian Healthcare Funding – Opportunity for the EU

A dip in Asian Healthcare Funding – Opportunity for the EU

6/5/2021

Q1 funding in the Healthcare sector has brought various changes and speculation. The European Union and the EU Market have strong growth potential.
New MDR and IVDR leave Manufacturers in Doubt as guidelines issued for Northern Ireland

New MDR and IVDR leave Manufacturers in Doubt as guidelines issued for Northern Ireland

4/5/2021

New guidance from the United Kingdom’s government keeps Northern Ireland in a farce. The UK issues separate guidelines for Great Britain and NI
#ScalingOurLegacy - GTC Celebrates 25 + years of Service

#ScalingOurLegacy - GTC Celebrates 25 + years of Service

29/4/2021

Med-Di-Dia Congratulates Galway Technology Centre on #ScalingOurLegacy celebrating 25+ years of Service. Highlights from the virtual event!
MDCG Recent Guidance on MDR, IVDR

MDCG Recent Guidance on MDR, IVDR

28/4/2021

The European Commission’s Medical Device Coordinating Group (MDCG) recently issued new guidance which explains the role of safety and performance standards under current and incoming Medical Dev...
What are the responsibilities of the EU Authorised Representative?

What are the responsibilities of the EU Authorised Representative?

11/9/2020

What are the responsibilities of the EU Authorised Representative?
Can I appoint my distributor as my EU Authorised Representative?

Can I appoint my distributor as my EU Authorised Representative?

10/9/2020

Can I appoint my distributor as my EU Authorised Representative? With the rush to ensure that UK based companies can continue to place their product on the market following Brexit, some companies...
Brexit – Time to have an EU Authorised Representative (EC Rep) in place

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

10/9/2020

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?

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

19/6/2020

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!

That was the week that was!

20/9/2019

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?

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

10/9/2019

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

Impact of Brexit on UK and EU based Medical Device Manufacturers

28/8/2019

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?

Brexit seems to be getting closer to being a reality?

28/7/2019

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

EU Commission needs your feedback - single-use medical devices

28/7/2019

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 Domino Effect?

9/7/2019

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’

Another EU Notified Body leaves the ‘pond’

16/6/2019

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??

Europe vs. US - is the tide turning??

7/6/2019

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

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

23/5/2019

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 …

The Clock is Ticking …

22/5/2019

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

New website for Med-Di-Dia

13/5/2019

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

New home for Med-Di-Dia

14/12/2018

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.