News

Black Friday & Cyber Monday Exclusive: Free Strategy Call for Digital Health Innovators – Appoint Med-Di-Dia as Your Regulatory Risk Partner!

25/11/2024

Navigating the fine line between wellness devices and medical devices can feel overwhelming. Whether you're working on Software as a Medical Device (SaMD) or Artificial Intelligence as a Medical ...

Irish Health institutions that manufacture and use in-house IVDs are now required to notify HPRA of their activities.

28/10/2024

This notification process ensures that the health institution complies with national and EU regulations.

Service Overview for In-House Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices

22/10/2024

With our deep expertise in EU regulations and compliance, we ensure that your institution meets all the legal requirements while streamlining the notification process with the Health Products Regulato...

AI-Driven Medical Device Regulatory Compliance: New Article by Dr. Shahram Ahmadi Published in RAPS RF Quarterly

24/9/2024

Dr. Ahmadi’s article delves into the evolving regulatory landscape and outlines how global regulatory bodies are adapting to the rise of AI/ML-enabled medical devices.

World Patient Safety Day 2024: "Get it Right, Make it Safe!"

16/9/2024

Get it Right, Make it Safe!

MDCG 2021-5 Rev. 1: A Closer Look at Standardisation for Medical Devices

2/7/2024

New Updates in MDCG 2021-5 Rev. 1: A Closer Look at Standardisation for Medical Devices

Med Tech Innovation Expo 2024 Birmingham and Med-Di-Dia

24/5/2024

Med-Di-Dia has taken a step further and collaborated with several partners to maximise the advantages of this gathering.

Join Us at the MedTech Innovation Expo and Conference!

24/5/2024

We at Med-Di-Dia are thrilled to announce a pioneering event coming your way.

IVDR Amendment

25/4/2024

The European Parliament voted in favour of the European Commission’s proposal.

MDCG 2024-4 Safety Reporting in Performance Studies of IVDs under IVDR

17/4/2024

This guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional.

MDCG 2022 – 9 Rev. 1

15/4/2024

Summary of safety and performance Template

Support for QMSR

3/4/2024

Save the Date: Thursday, May 23rd, 1pm to 2pm Irish Time

Med-Di-Dia x Digital Health Copenhagen

2/4/2024

Dr Shahram Ahmadi, will join the panel hosted by Digital Health Copenhagen.

Ambitious Essex Innovation Accelerator and Med-Di-Dia

27/3/2024

Eliminating Regulatory Risk! One step at a time.

Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

8/3/2024

Med-Di-Dia and Global Regulatory Services (GRS) are thrilled to announce a fireside chat-style LinkedIn Live session

Proposed extension of Transitional Timelines for IVDR

8/3/2024

Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply.

January 2024 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

15/2/2024

The document provides a timeline and a status for each priority action, as well as the actors involved in their implementation. It also serves as a living document to monitor the progress of the work ...

ISO 13485 for USA QSR to QMSR

2/2/2024

The USFDA’s recent decision amends CGMP and requires the adoption of ISO 13485!

Device Specific Vigilance Guidance

31/1/2024

Check out the post-market guidance issued by MDCG under their Device Specific Vigilance Guidance.

The UK unveils a new roadmap for medical device regulations.

15/1/2024

The UK government has announced a new plan to develop a robust and innovative regulatory framework for medical devices to enhance patient safety and access to cutting-edge technologies.

Med-Di-Dia Ltd Celebrates Triumph as Best Medical Compliance Consultants 2023 in Ireland

14/1/2024

Best Medical Compliance Consultants 2023 in the Republic of Ireland

ECDRP replaced by IRP in the UK

5/1/2024

If the medicine is co-packaged with a medical device component which isn’t EU CE or UKCA marked then Recognition B will be the mandatory application route.

Expansion Announcement: Strengthening Med-Di-Dia's Regulatory Expertise

7/11/2023

New team members joining our mission!

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

27/10/2023

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

Medical Technology Ireland and Med-Di-Dia.

29/8/2023

Join us to get the latest insights.

The Future of Swedish & Danish Life Science and Med-Di-Dia

29/8/2023

Networking Opportunity

MDR Transitional Timeline Flow Chart.

25/8/2023

Dos your device meet the requirements?

MedTech in the EU and USA!

14/8/2023

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

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

18/7/2023

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

Harmonised standards for sterilisation of health care products

11/7/2023

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

Medical Device Regulations 2023 – UK Amendments

20/6/2023

Is the UK shadowing EU medical regulations?

EU MDR

26/5/2023

Recent Developments as the industry aims for the Future!

MDCG 2020 -3 Rev 1

18/5/2023

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

3/5/2023

Changes in the EU resulting in amendments in the UK!

EUMDR Transitional Provisions – Deep Dive

20/3/2023

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

EU MDR Timeline

7/3/2023

Extension of EU MDR Transitional Timelines

MDCG 2020-16 Rev 2

27/2/2023

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

24/2/2023

Quick Summary to MDCG 2023 - 3 Guidance

Best Medical Regulatory & Quality Compliance Consultancy

5/1/2023

Awards and recognitions motivate us to work more efficiently!

MedTech Regulatory Updates in EU

16/12/2022

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

Common Specifications for Borderline Medical Devices in EU

5/12/2022

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

5/12/2022

EU MDR is getting serious. Dead Serious!

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

7/11/2022

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

2/11/2022

MDCG issued a guidance for EU ARs under MDR and IVDR

Notified bodies survey on certifications and applications

27/10/2022

Interesting facts and updates for MDR IVDR

MedTech Cyber Security in EU

11/10/2022

Team NB publishes position paper

SEHTA 2022 International MedTech Expo & Conference

10/10/2022

Meet Our Expert at SEHTA 2022 International MedTech Expo & Conference

MDCG 2022 15

23/9/2022

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

13/9/2022

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

26/8/2022

MDCG position Paper – Transition to the MDR and IVDR

IVDR Update related to EUDAMED

14/7/2022

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

12/7/2022

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

7/7/2022

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

4/7/2022

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

1/7/2022

Happy Birthday to ME!!

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

27/6/2022

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

MDCG 2022-11

13/6/2022

MDCG issues notice to Manufacturers.

Quality Management Workshop Codex4SMES

30/5/2022

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

30/5/2022

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

30/5/2022

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

26/5/2022

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

Summary of safety and performance Template – MDCG 2022-9

25/5/2022

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

Questions and Answers on the Unique Device Identification system

23/5/2022

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

20/5/2022

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.

4/5/2022

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...

Seeking Regulatory Affairs Consultants

4/5/2022

We’re hiring!

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

26/4/2022

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

IVDR Celebration Week

13/4/2022

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

MDCG published A Summary of safety and clinical performance

28/3/2022

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

Regulatory Funding Opportunity for Health Tech SMEs

1/3/2022

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.

Joint implementation and preparedness plan for IVD Regulation. MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations

14/2/2022

MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations.

Updates for SaMD using Blockchain

10/2/2022

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)

27/1/2022

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

IVDR Regulation Amendment Update

25/1/2022

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.

13/1/2022

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

8/1/2022

The new year has started with new decisions and publications.

Medical Technologies and Advancements

27/10/2021

What does Digitalisation bring to MedTech?

Pandemics - Future and Present

25/10/2021

Pandemic - Present and Future

Classification of Medical Devices.

12/10/2021

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

Future of Medical Device Regulations

5/10/2021

Regulations in the United Kingdom

Friday Weekly Run Through 01 October

1/10/2021

Enjoy your Friday with a MedTech Snippet

Clouding Medical Industry!

28/9/2021

The medical industry sees a big boom in Cloud Investments…

75% IVDs may Lack IVDR Certification!

21/9/2021

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

Friday Weekly Run Through

17/9/2021

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

Software Freedom Day

15/9/2021

Med-Di-Dia Celebrates Software Freedom Day!

Global Collaboration - Ireland and India

14/9/2021

A step towards Global Collaboration!

8 Challenges Affecting Medical Devices

7/9/2021

Top challenges affecting Medical Device Manufacturers.

Hiring Alert

30/8/2021

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

Clinical Trials Information System (CTIS)

5/8/2021

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!

3/8/2021

Read about how tech is supporting counselling services for children.

Notified Bodies – Total 27

22/7/2021

Read about the latest regulatory update.

Swiss MedTech and EU MDR

20/7/2021

Swiss MedTech and the EU MDR

Med-Di-Dia's Presentation On Helix!

15/7/2021

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

8/7/2021

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

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

5/7/2021

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

1/7/2021

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

EU MDR and the United Kingdom.

29/6/2021

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.

22/6/2021

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.

17/6/2021

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

The future of Wearable Devices.

15/6/2021

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.

9/6/2021

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?

8/6/2021

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

3/6/2021

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

1/6/2021

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

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.

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

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

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!

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!

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

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

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

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

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

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?

11/9/2020

What are the responsibilities of the 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

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?

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!

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?

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

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?

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

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?

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’

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??

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

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 …

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

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

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.

Search by year:

Knowledge Center