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MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations


Guidance on MDSW intended to work in combination with hardware or hardware components.

Medical Technology Ireland and Med-Di-Dia.


Join us to get the latest insights.

MDR Transitional Timeline Flow Chart.


Dos your device meet the requirements?

MedTech in the EU and USA!


A webinar for Medical Manufacturers looking to sell in the EU and USA.

Manufacturer’s Declaration in relation to Regulation (EU) 2023/607


MedTech Europe* is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers.

Harmonised standards for sterilisation of health care products


The deadline for compliance with the new requirements is 20th July 2023.

Medical Device Regulations 2023 – UK Amendments


Is the UK shadowing EU medical regulations?



Recent Developments as the industry aims for the Future!

MDCG 2020 -3 Rev 1


Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

MDR in the EU and UK


Changes in the EU resulting in amendments in the UK!

EUMDR Transitional Provisions – Deep Dive


Certain Medical Devices have the advantage of an extended transitional period!

EU MDR Timeline


Extension of EU MDR Transitional Timelines

MDCG 2020-16 Rev 2


Here are some key points that medical device manufacturers should keep in mind from MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under IVDR.

MDCG 2023-3 Guidance


Quick Summary to MDCG 2023 - 3 Guidance

Best Medical Regulatory & Quality Compliance Consultancy


Awards and recognitions motivate us to work more efficiently!

MedTech Regulatory Updates in EU


Find all the Regulatory Updates for Medical Devices, Diagnostics and Digital Health in EU!

Common Specifications for Borderline Medical Devices in EU


On December 01, 2022, the European Commission published Document C(2022)8626 - laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to R...

List of Common Specifications under Annex XVI – EU MDR


EU MDR is getting serious. Dead Serious!

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)


This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in principle in the MDCG meeting of 28 May 20...

MDCG 2022 16


MDCG issued a guidance for EU ARs under MDR and IVDR

Notified bodies survey on certifications and applications


Interesting facts and updates for MDR IVDR

MedTech Cyber Security in EU


Team NB publishes position paper

SEHTA 2022 International MedTech Expo & Conference


Meet Our Expert at SEHTA 2022 International MedTech Expo & Conference

MDCG 2022 15


Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

Manual on Borderline


Borderline cases are those for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not.

MDCG 2022 14


MDCG position Paper – Transition to the MDR and IVDR

IVDR Update related to EUDAMED


MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

Funding competition Fast Start Innovation


UK registered small and micro businesses can apply for a share of up to £30 million for affordable, adoptable and investable innovations in net zero and Healthcare.

EUDAMED Timeline


Quite Recently, The European Commission published the timeline of when will this system be in place, functional and enforced for mandatory use.

laying down common specifications for certain class D in vitro diagnostic medical devices


Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 o...

MDD Turns 3


Happy Birthday to ME!!

Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK


Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK.

MDCG 2022-11


MDCG issues notice to Manufacturers.

Quality Management Workshop Codex4SMES


There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Economic Operators Workshop Codex4SMES


There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Workshop for SMEs


The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different work...

Welcoming IVDR


Med-Di-Dia Welcomes In-Vitro Diagnostic Regulations #IVDR #IVDRReady

Summary of safety and performance Template – MDCG 2022-9


MCDG Published a template for summarising the safety and performance requirements.

Questions and Answers on the Unique Device Identification system


MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG Guidance 2022-8


MDCG Publishes Guidance on Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Direc...

MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.


In order to benefit from the transition periods provided in Article 110(3) IVDR, devices may not undergo any significant change in the design or intended purpose after the date of application of the I...



This report highlights the updates from the implementation of Medical Device Regulations – MDR and upcoming In-Vitro Diagnostic Regulations – IVDR.

IVDR Celebration Week


series of weeklong fireside chats to celebrate the incoming IVD Regulations in the European Union.

MDCG published A Summary of safety and clinical performance


This summary of safety and clinical performance is a guide for manufacturers and notified bodies.

Regulatory Funding Opportunity for Health Tech SMEs


If you are an SME working in HealthTech, you can apply for up to £30,000 of funding for use with regulatory affairs providers, to help you navigate regulatory pathways.

Updates for SaMD using Blockchain


EU Blockchain Observatory and Forum introduces a thematic report on Blockchain Applications in the healthcare sector.

Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)


MDCG 2022-2 releases Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs).

IVDR Regulation Amendment Update


In response to the proposal sent on 14.10.2021 with regards to a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certa...

MDCG advice for non EU/EEA SARS-CoV-2 infection IVD Manufacturers.


MDCG 2022-1 (January 2022) - Addressees IVD manufacturers with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection

Harmonised standards updated for MDR IVDR


The new year has started with new decisions and publications.

Medical Technologies and Advancements


What does Digitalisation bring to MedTech?

Pandemics - Future and Present


Pandemic - Present and Future

Classification of Medical Devices.


October brings in clarification on the classification of different medical devices under the EU MDR.

Future of Medical Device Regulations


Regulations in the United Kingdom

Friday Weekly Run Through 01 October


Enjoy your Friday with a MedTech Snippet

Clouding Medical Industry!


The medical industry sees a big boom in Cloud Investments…

75% IVDs may Lack IVDR Certification!


MedTech Europe warns IVD manufacturers might not be able to certify their product before the deadline.

Friday Weekly Run Through


Presenting Med-Di-Dia Friday Weekly Run Through for 17th September 2021 All things MedTech and Regulatory

Software Freedom Day


Med-Di-Dia Celebrates Software Freedom Day!

Global Collaboration - Ireland and India


A step towards Global Collaboration!

8 Challenges Affecting Medical Devices


Top challenges affecting Medical Device Manufacturers.

Hiring Alert


Med-Di-Dia is Hiring for Business Development and Marketing Coordinator

Clinical Trials Information System (CTIS)


The EU Clinical Trials Information System (CTIS) will go live on 31 January 2022 - why does this matter to MedTech? Read on

Tech Supporting Medical Services!


Read about how tech is supporting counselling services for children.

Notified Bodies – Total 27


Read about the latest regulatory update.

Swiss MedTech and EU MDR


Swiss MedTech and the EU MDR

Med-Di-Dia's Presentation On Helix!


07th July, Med-Di-Dia and its partners presented insights as a part of the ON Helix Innovations workshop. Read more…

Latest Guidance on UDI by USFDA


Just in: Latest Guidance issued by USFDA. Find out more here…

Med-Di-Dia Takes Part in Innovation Workshop with ON Helix


The One Nucleus community organises ON Helix Innovation workshops, and this time, Med-Di-Dia is participating with its Partners. Read More

Med-Di-Dia Turns 2


Started in 2019 - Embraced the Pandemic and now we are here! Read our celebrations!

EU MDR and the United Kingdom.


With complex developments in the regulatory framework, it is vital to stay up-to-date. Read on to know more about the EU MDR and the United Kingdom.

COVID-19 Survey by the EU Commission.


With the onset of COVID-19 vaccination and recovery, companies are developing new treatments and therapies. Read more about the survey.

Med-Di-Dia and Thomas Regulatory Resolutions are using the social media platform to spread awareness about medical device regulatory affairs.


Using the advantage of the digital space, bustling medical device regulatory service providers are going LinkedIn Live!

The future of Wearable Devices.


With advancing technology and MedTech Innovations, the future brings challenges as well as opportunities for wearable devices.

Cambridge Academy of Therapeutic Sciences announces seminar with Med-Di-Dia.


It is crucial to ensure that you are constantly updated in the dynamic and ever-developing medical world. Therefore, organisers at the Cambridge Academy of Therapeutic Sciences have initiated a semina...

EU MDR - what’s happening with Switzerland?


Before 26th May 2021, medical devices had restriction-free movement between Switzerland and the EU market. Since MDR was fully implemented throughout Europe from 26th May 2021, and with the breakdown ...

MedTech Europe warns of ongoing regulatory issues


MedTech Europe welcomed the first wave of new E.U. medical device regulations last week but said there’s work that’s yet to be done.

Med-Di-Dia Team Expansion


Welcoming the new set of Professionals. Med-Di-Dia Team is expanding. We aim at creating strong regulatory support for our Clients.

The US FDA releases draft guidelines for Medical Devices


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.


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


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


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!


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!


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


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


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 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


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


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?

Can I appoint my distributor as my EU Authorised Representative?


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

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.