Spring is on its way

As we start to see the first buds of Spring appear, there is plenty of development in the Med Tech industry too... 

MHRA’s Med Tech Regulatory Reform webinar 

 

On 5th March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) presented the first in a series of webinars that they are billing as “Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK”.

 

This online session sought to provide insight into the scope of future new legislation in the UK, the proposed changes to the classification system, and the move from Essential Requirements to General Safety and Performance Requirements.  If this is sounding anything like the EU MDR or EU IVDR then you have already got the main message: the UK will follow the EU regulations and IMDRF.

 

Robin attended the webinar and has summarised the findings in a blog, which you can find on our website at www.psephos.com/blog

 

FDA Final Rule: Medical Device Quality System Regulation Amendments

 

For many years the rest of the world has been utilising the ISO 13485 Medical Device Quality Management System standard as a means for companies to show compliance to regulatory requirements and to ensure safe and effective products are placed on the market. The US FDA is now revising its medical device Current Good Manufacturing Practices (CGMP) requirements as set forth in the QSR.

This is a major change.

 

To find out more, visit our website and read the blog: “FDA Final Rule: Medical Device Quality System Regulation Amendments”. www.psephos.com/blog

Notified Bodies Survey

 

The revised version of the Notified Bodies Survey on certifications and applications for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was published on 13th March. The survey provides comprehensive insights into the certification and application processes overseen by Notified Bodies. It is great to see an increase in the number of Notified Bodies listed and the number of submissions. However, only

37.9% of the total MDR applications submitted resulted in certificates being issued, while for IVDR, 46.8%. A significant portion of MDR applications did not lead to certificate issuance. The data indicates that the certification processes under MDR and IVDR regulations can range from a few months to over a year, depending on the type of certificate and the Notified Body involved.

 

The revised version can be found here: https://health.ec.europa.eu/latest-updates/updated-document-notified-bodies-survey-certifications-and-applications-mdrivdr-survey-results-data-2024-03-13_en

 

If you would like to discuss further, please contact us below.

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