Notified Bodies

Medium and high risk devices, including active implantables and relevant in vitro diagnostic medical devices, and those Class I medical devices supplied sterile or which have a measuring function require the use of a Notified Body to carry out a compliance assessment in accordance with the chosen route to compliance before manufacturers can place their products on the market.

Notified Bodies are designated by the Competent Authorities in the Member States. MHRA have produced a bulletin which provides some relevant background information (Bulletin 6 - The Notified Body)

A manufacturer can use any Notified Body in Europe that is designated (approved) under the appropriate Directive and has a scope that accommodates the manufacturer’s device types and chosen compliance route. A list of the UK Notified Bodies is also available.

A list of all European Notified Bodies (external link) under each Directive can be obtained from the European Commission website.

In order to be designated, Notified Bodies must meet stringent criteria contained in the Regulations and Directives. MHRA has produced a set of requirements for UK Notified Bodies (Guidance Note No 6 - Requirements for UK Notified Bodies), which is almost identical with the European guidance (MEDDEV 2.10/2 - Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices) (external link) and its Annexes.

Potential UK Notified Bodies should initially contact Tore Johansen at  MHRA, Room 8/2-A02, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (Tel : 020 7084 3235, Fax : 020 7084 3112, email : tore.johansen@mhra.gsi.gov.uk) for application information.

After successful designation, MHRA monitors UK Notified Bodies by regular audits and by witnessing their compliance assessment of manufacturers. Both designation and monitoring is subject to fees. An amended scale of fees will apply from 1 April 2010.  The new fees are implemented by the Medical Devices (Fees Amendments) Regulations 2010, Statutory Instrument 2010 No. 557 (external link).

 

Designation applications

Fees applicable from 1 April 2010

Application for designation

£3,840

Re-application to address ground for rejection of a previous application

£960

Application for extension to scope

£1,880

Audits

Initial designation audit

£4,670

Surveillance

£3,840

Additional fee for each additional initial and/or surveillance audit conducted at the same time as NB audit/other MRA activity

£1,920

Witnessed audit

£3,840

In addition to each of the above, fees for time spent on audit and travel

½ day rate for auditing

£271

Hourly rate for travel to and from audit and actual costs of accommodation, travel, subsistence and out of pocket expenses

£75.24


Payment can be made by cheques payable to "MHRA" or by BACS/CHAPS.

If a payment is submitted via BACS/CHAPS you will need to quote the invoice number that your payment relates to, and your customer account number. You can locate both the invoice number and customer account number on the invoice issued by the MHRA. Please note, quoting this information will enable our Finance section to allocate your payment to the correct transaction.

From 22 February 2010 all sterling and other foreign currency payments should now go to:

Account name: GBS Re MHRA
Account number: 12314800
Sort code: 08-33-00
Swift code: CITIGB2L
Iban: GB05CITI08330012314800

Branch address:
Citibank N.A.
London Branch
Canary Wharf
London
E14 5LB

Further information regarding the change to our bank details

Further guidance and information about the designation and monitoring of Notified Bodies is contained in the Designating Authorities Handbook (external link) on the European Commission website.


Page last modified: 01 April 2010