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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.

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!

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