Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

Maria

UKRP for Medical Devices

AF Pharma’s UKRP for medical devices helps EU companies navigate UK compliance, boosting market entry and growth for manufacturers across EU

Maria

UKRP (UK Responsible Person)

A UKRP (United Kingdom Responsible Person) represents non-UK medical device manufacturers, ensuring compliance with UK regulations.

Maria

New MHRA Roadmap

MHRA's 2024 roadmap enhances UK medical device regulations, prioritizing patient safety, AI/ML guidelines, and international harmonization.

pharmaserviceinc

Draft UK Post-market Surveillance Requirements

We have some exciting news to share regarding the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has recently...

pharmaserviceinc

💊💊 BREAKING PHARMA NEWS- MHRA Medicines and future Medical devices updates! 💉💉

MHRA has just announced new regulatory recognition routes for MEDICINES.

Soledad

MHRA Updated Guidance on Software: Understanding Medical Device Status and Regulation

In the ever-evolving field of medical devices, software applications (apps) are playing an increasingly significant role. To ensure the...

Soledad

Regulating medical devices in the UK - April update

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. This is an extract...

Soledad

Foods for special medical purposes/medical foods: A global regulatory synopsis

Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.

Soledad

UKCA Marking - extension of standstill period

The MHRA explained its intention to extend the standstill period of using the CE Mark by 12 months to 30 June 2024 for the medical devices.

UPDATED GUIDANCE MHRA

This guidance document replaces the previous MHRA guidance titled “medical device standalone software, including apps”.