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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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New AI Act Regulation
Europe's AI Act enforces transparency, safety, and accountability in AI, ensuring responsible use and protecting consumers from risks.
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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
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