December 2023 News Letter

As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year.  What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective?  The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification - May 2024 We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.
image of a card with the ISO logo on it in blue - this is used to represent content displayed by patient guard relating to medical device and IVD regulatory affairs and quality assurance as well as standards
Facebook
X
LinkedIn

December News

As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year.  What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective? 

The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024

We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.

EU MDCG Guidance Updates in December 2023

The Following New or Updated MDCG guidance documents were issued in December 2023:

If you sell medical devices on the EU market you should check to ensure that you are following the latest guidance issued by the EU commission, MDCG documents can be found here.

image of a card with the ISO logo on it in blue - this is used to represent content displayed by patient guard relating to medical device and IVD regulatory affairs and quality assurance as well as standards

Medical Device Standards Updated in December 2023

Medical Device Standards issued or updated in December 2023

Most Popular

Understanding Medical Device System and Procedure Packs under the EU MDR: What Manufacturers Need to Know

June 14, 2025

The European Union Medical Device Regulation (EU MDR) 2017/745 significantly reshaped the regulatory landscape for medical devices in Europe. One area that continues to cause confusion for manufacturers, distributors, and assemblers alike is the regulation of system and procedure packs. These are specific types of medical device groupings that, while not always requiring full CE marking as a new device, are still tightly regulated under Article 22 of the MDR.

Read More »
patient guard
Patient Guard

Sign up to our newsletter

Be the first to hear industry news and how Patient Guard can help you.

Patient Guard Logo
Facebook-f X-twitter Instagram Linkedin-in Youtube
UK Office

Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP

German Office

Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen, 
Deutschland / Germany

Quick Links
Copyright © Patient Guard | Website design and marketing by Sharp Ahead

Get the Medical Device Technical Checklist

Thank you! The checklist is now ready to download.

Download Now

Speak to one of our medical device consultants

For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.

UK Office

Do you need support with Medical Device or IVD compliance?

We can help you!