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Get UK MHRA RG2 Registration Form 2015-2024

It may also help us if a picture or technical diagram of the device is also provided in addition to the completed registration form. Please also provide a general/generic description name for the product s you wish to register. You should avoid specific brand names or devices types as any changes to the registration details held incurs payment of our statutory fee. Note the MHRA will not accept a product catalogue/brochure as a means of application for registration. The MHRA generic device codes for class I custom made and/or systems and These lists are for guidance only and there are likely to be many more devices than those listed here. 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 the business letter attached Payment attached Further info required documents Info / payment/ Proceed with registration Part 1 About the registration notification Please read the accompanying guidance notes before commencing. Complete in type face or block letters. The form may be copied if required Day Month Year 1. Enter the date of notification 2. Please indicate if this is the first registration or change of information* First Change If change please provide previous reference number CA 3. Indicate the status of the organisation making this registration notification by ticking the appropriate box. Manufacturer Authorised representative Assembler of System and procedure packs Regulation 11/ Article 12 Custom Made Active Implantable Device please include the instruction for use with the RG2 form 4. The statement below must be completed by an authorised signatory of the manufacturer authorised I print full name affirm that the information provided in this notification is accurate and that the Class I devices/custom-made devices/system and procedure packs Regulation 14/Article 12 delete as appropriate covered by this notification meet the provisions of the Regulations which apply to them* Signed Date Position Manager/Owner/CEO CFO Proprietor etc Company name if applicable August 2013 Page 1 of 12 Part 2 manufacturer information UK address 5. Enter the full name and postal address of the manufacturer or person responsible for placing the device s on the market if based in the UK. This relates to the address information on the labelling or packaging. Company/Manufacturer s name or person responsible name used here should be the same as that used on declaration Address PO Box address in not acceptable Please note we will require an additional contactable source e*g* fax/email address Telephone Fax number or email of the manufacturer if based outside the EU. .

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