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The US FDA releases draft guidelines for Medical Devices

The US FDA releases draft guidelines for Medical Devices

27/5/2021

The US FDA released draft guidelines for neurostim, other devices to treat diabetes and guidance for Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
EU plans to enforce additional regulations on MedTech AI products, other 'high-risk' systems.

EU plans to enforce additional regulations on MedTech AI products, other 'high-risk' systems.

25/5/2021

AI and SaMD are the future of MedTech development. In these times, such stringent regulations could be seen to hamper the industry's capacity to innovate.
Report from Deloitte Spotlights the Trend for Virtual Care

Report from Deloitte Spotlights the Trend for Virtual Care

20/5/2021

Virtual care in the pre-pandemic era was considered a slow-moving industry. Investors have heavily invested their stakes in virtual health and care management technology.
Main changes introduced by the MDR for Class I Device Manufacturers

Main changes introduced by the MDR for Class I Device Manufacturers

18/5/2021

All medical device companies will be affected by new developments under MDR, which comes into effect on 26th May 2021. Everyone operating in the medical device sector will be affected one way or anoth...
UDI Helpdesk by the EU Commission!

UDI Helpdesk by the EU Commission!

17/5/2021

Just in time, the European Commission has launched a UDI helpdesk to support EU MDR Economic operators.
Synergies of HealthCare and Technology are leading the way!

Synergies of HealthCare and Technology are leading the way!

13/5/2021

Where regulation continues to be a restraint, MedTech Companies are critical to the success factors for developing digital health care infrastructure, but these companies need to gain fast-paced momen...
Medical Devices are Trending! Here is your Trend Guide

Medical Devices are Trending! Here is your Trend Guide

11/5/2021

By 2021, technological advances are accelerating the revolution in the medical device industry while giving rise to new opportunities and new challenges.
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...

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