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ISO 13485 for USA QSR to QMSR

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

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.

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

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

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

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

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.

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

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

29/8/2023

Networking Opportunity
MDR Transitional Timeline Flow Chart.

MDR Transitional Timeline Flow Chart.

25/8/2023

Dos your device meet the requirements?
MedTech in the EU and USA!

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

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

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

Medical Device Regulations 2023 – UK Amendments

20/6/2023

Is the UK shadowing EU medical regulations?
EU MDR

EU MDR

26/5/2023

Recent Developments as the industry aims for the Future!
MDCG 2020 -3 Rev 1

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

MDR in the EU and UK

3/5/2023

Changes in the EU resulting in amendments in the UK!
EUMDR Transitional Provisions – Deep Dive

EUMDR Transitional Provisions – Deep Dive

20/3/2023

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

EU MDR Timeline

7/3/2023

Extension of EU MDR Transitional Timelines
MDCG 2020-16 Rev 2

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.

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