MHRA Designated Standards Survey Newly Launched

On September 5^th, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a designated standards survey to identify which technical standards for medical devices and IVDs should be prioritized for formal designation under the UK Medical Devices Regulations 2002. 

Why this MHRA Designated Standards Survey Matters 

Designated standards give manufacturers a presumption of conformity with regulatory requirements, helping streamline compliance and market access in Great Britain. 

Who Should Respond: 

• Manufacturers of medical devices and IVDs supplying the GB market 

• Approved Bodies involved in conformity assessment 

• Industry associations and trade groups 

• Healthcare professionals, users, and purchasers of devices 

• Other stakeholders relying on standards for regulatory compliance and patient safety 

Survey Focus Areas: 

• Importance and use of currently designated standards 

• Suggestions for standards not yet designated, including updates or replacements 

• Organizational views on benefits and efficiency of designated standards 

• Demographic insights from different stakeholders 

You can find the full designated standards MHRA survey here.

How MedEnvoy Can Support 

MedEnvoy offers expert regulatory support to manufacturers in navigating MHRA designated standards survey requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.