Medical Device Blog

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

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UKRP (UK Responsible Person)

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

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Regulatory Landscape for Custom-Made Medical Devices in the EU

Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes

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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...

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Examples of Class IIb medical devices

Medical device classification examples. Class IIb under MDR rules.

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Examples of Class IIa medical devices

Medical device Class IIa examples

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Examples of EU Medical Device - Class I

Examples of medical devices classes

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Medical Device User Fee Amendments (MDUFA)

User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the establishment registration fee. There...

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Medical Device Labelling Requirements

A label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each...

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CONCLUSIONS FOR A CLINICAL EVALUATION - MDR

A successful clinical investigation for Medical Device Regulation EU 2017/745 (MDR) is one that generates scientifically valid clinical...

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Declaration of conformity for medical devices

The Declaration of Conformity (also known as DoC) is a critical document for every medical device in Europe.

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Are you looking for an MDR Technical File template?

MDR Technical File template