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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Guidance on the approach to ensure that instruments placed on the market conform to the Measuring Instruments Directive.
Compare different evaluation approaches and choose an appropriate method.
Guidance for suppliers and dealers.
How to use a before-and-after study to evaluate your digital health product.
How to use an interrupted time series to evaluate your digital health product.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
How to use an economic evaluation to evaluate your digital health product.
Guidance for businesses.
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Approval process for gas and electricity meters under the Measuring Instruments Directive (MID 2014/32/EU).
The rules about product labelling - including special rules for retailers and manufacturers in different business sectors (like food, jewellery and toys)
Register a new manufacturer's mark and access lists of approved and inactive measuring container bottles (MCB) marks.
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