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Competent Authority UK Medical Devices Regulations 2002 No* 618 Regulations 19 and 30 Form RG2 registration of medical devices For office use only Date of receipt Evidence in support of application checklist Authorised representative application Y/N Designation letter attached Applications replacing an existing AR need a cancellation of their contract/agreement from the overseas manufacturer has the new AR attached it to this registration Details of the device s fully provided Legal entity of ...

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How do I register my device with MHRA?

In order to submit any registrations to MHRA you must first log-in to DORS. To do this you will need to enter your account number, email address and password. Once logged in a page will appear that lists all requested registration details for your account.

What is the UK version of FDA?

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

What is the FDA called in Europe?

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products.

What is considered a medical device in the UK?

Medical devices A medical device is any instrument (other than a medicine) that is used to diagnose, monitor, treat or manage a medical condition. The definition covers a wide range of products including syringes, dressings, surgical tools, scanners, software, apparatus, machines and some medical apps.

What is FDA UK?

FDA The United Kingdom Medicines and Healthcare Products Regulatory Agency, Confidentiality Commitment.

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Is MHRA similar to FDA?

Similarly to the MHRA in the UK, the FDA is the medical regulatory body in the USA and is responsible for the licensing of medications depending on their efficacy following clinical trials.

What is the UK mark for medical devices?

The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland).

What is the difference between the FDA and the EMA?

The FDA is a centralized agency that oversees the drug development process in a single country, whereas the EMEA is a reviewing body that manages the process in many European nations.

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