The Regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.
There are currently three sets of Medical Device Regulations implementing all of the Medical Devices Directives and amendments to date; Statutory Instruments 2002 No. 618 (Consolidated legislation), 2003 No. 1697 (Amendments to cover the re-classification of breast implants and additional requirements covering devices utilising materials from TSE susceptible animal species) and Medical Devices Regulations 2007 No. 400 (Amendment to cover the re-classification of total hip, knee and shoulder joints). They have been issued under the Consumer Protection Act and can be found on the Office of Public Sector Information (OPSI) (external link) website.
Other useful information can be found on the European Commission's (external link) website covering the medical devices sector.
Medical Devices Directive
Directive 93/42/EEC covers the placing on the market and putting into service of Medical Devices.
It covers an extremely wide range of products, including, for example:
- first aid bandages
- tongue depressors
- hip prostheses
- X-ray equipment
- ECG
- heart valves
- spectacles
- dental materials
A copy of the directive (external link) can be found on the Europa website.
A number of additional Directives amending the original Directive have since been introduced:
- Directives 2000/70/EC (external link) and 2001/104/EC (external link) which brought medical devices incorporating stable blood derivatives within the scope of the general directive.
- Directive 2003/12/EC (external link) which reclassified breast implants into Class III.
- Directive 2003/32/EC (external link) which lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalopathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-variable or non-viable products derived from animal tissue.
- Directive 2005/50/EC (external link) which reclassifies total hip, knee and shoulder joints into Class III.
- Directive 2007/47/EC (external link) which doesn’t come fully into force until 21 March 2010 but will amend the Medical Devices and Active Implantable Medical Devices Directives following a review of the existing provisions by the European Commission and member states.
- Interpretative documents (external link)
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) (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 E-mail : 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 2008. The new fees are implemented by the Medicines for Human Use and Medical Devices (Fee Amendments Regulations 2008, Statutory Instrument 2008 No. 530 (external link).
Registration of medical devices
Registration of medical devices, including In Vitro diagnostic products.
Changes to the Medical Devices Regulations
Directive 2007/47/EC amends the Active Implantable Medical Devices Directive 90/385/EC and comes into force on 21 December 2008. One change to the Directive especially affects persons responsible for placing and putting into service custom made active implantable medical device(s) on the EU market.
Article 1. 11 of Directive 2007/47/EC amends Article 10 of Directive 90/385/EC to include a requirement for manufacturers of custom made active implantable medical devices to provide the competent authority of the Member Sate in which they have their registered place of business details of their address, a description of the device(s) concerned, the product labelling and the instructions for use.
The revisions to the Directives have been transposed into UK law, under the Medical Devices (Amendment) Regulations 2008, and came into force on 21 December 2008. However the regulations only become mandatory on 21 March 2010. During this transitional period manufacturers of custom made active implantable medical devices or their designated authorized representatives are not required to register their details with the UK Competent Authority, however they may wish to and can do so by completing the RG2 form. In addition to the completed form, manufacturers or their authorised representatives must also provide the Competent Authority with a copy of the device label and the instructions for use that will accompany the device.
Medical Devices Directive
The Regulations require manufacturers and authorised representatives based in the UK who are placing Class I or Custom Made devices to register with the MHRA details of themselves and the medical devices they are placing on the market. This also applies to products covered by Article 12 of the Directive including sterilizers and people carrying out assembly. Guidance for opticians and glazing shops is available under Ophthalmic products.
Guidance
The following guidance has been produced by the MHRA to assist with the registration process.
Additional information for Class I, System and Procedure Packs and Custom Made medical devices can be obtained via:
In Vitro Diagnostic Medical Devices Directive
The Regulations require manufacturers and authorised representatives based in the UK to register with the MHRA details of themselves and the IVDs they are placing on the market.
The EDMA IVD Product Classification System
The devices are required to be grouped together for registration purposes. Standardised groupings are required in order to facilitate the entry of, and access to, the registration data in the European database. Therefore, each device grouping has a numerical Group Code so that the groupings can be entered and accessed in a systematic and consistent manner which is independent of language.
It is intended by Member States that groupings from the Global Medical Devices Nomenclature System be used when the European database comes into operation. In the interim, the system generated by the European Diagnostic Manufacturers Association (EDMA) is to be used. The full system may be downloaded from the EDMA website (external link).
Guidance
The following guidance has been produced by the MHRA to assist with the registration process.
Additional information for in vitro diagnostic medical devices can be obtained via:
Providing the following information upon submitting your form, will enable us to process your registration faster:
Cost per registration
There is a statutory fee of £70.00 for new or subsequent changes to the registration details held with the MHRA. Payment can be made by cheques payable to "MHRA" or by BACS/CHAPS. At present we do not have the facilities to accept payments via credit/debit cards.
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.
BACS payments
Bank Name: Bank of England
Address: Government Counter, Threadneedle Street, London, EC2R 8AH
Sort Code: 10:14:99
Acc No: 06781000
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
Sterling CHAPS payments from a UK account
Bank Name: Natwest Bank
Address: 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL
Sort Code: 16:53:60
Acc No: 6781
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
For EURO currency payments from a Member State
Account Name: Office of the Paymaster General - EURO Receipts
Address: Natwest, 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL
Sort Code: 60:10:43
Acc No: 55001008304793
Swift Code: NWBKGB2L
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN: GB43NWBK60720608304793, OPG EURO Receipts Account
For Sterling currency payments from an Overseas Account
Account name: Office of HM Paymaster General - Euro Receipts
Account number: 41414985
Sort Code: 60 10 43
Swift Code: NWBKGB2L
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN: GB82NWBK60104341414985
OPG Euro Receipts Account
Branch Address:
Natwest Bank
6 Coldharbour Lane
Hayes
Middlesex UB3 3EL
For all Overseas Transfers
Account name: Office of the Paymaster General - Cash a/c
Address: Bank of England, Government Counter, Threadneedle Street, London, EC2R 8AH
Sort Code: 10:00:00
Acc No: 25021001
Swift Code: BKENGB33
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN: GB57BKEN10000025021001
Authorised Representative
Any manufacturer based outside the EU must designate an Authorised Representative (AR). The appointed AR must provide written evidence that they are acting with the consent of a manufacturer located outside the European Community. This may take the form of a letter of designation/contract from the overseas manufacturer.
The letter should state the full name and address of the AR and that they are the designated EU Authorised Representative based within the UK, under the MDD 93/42EC. In the case of a notification/registration for an In Vitro Diagnostic device please quote the Directive IVDD 98/79EC.
In the case of an overseas manufacturer employing a new AR; the MHRA will require a copy of the letter from the overseas manufacturer, to the old AR terminating their services, and the date the service/contact is due to end.
Change of Circumstance (COC)
So that we can establish whether the allocation of a new registration number is appropriate any registration where there has been a change of company name, or become a limited company; please provide written confirmation stating whether there has been/has not been a change in the legal entity of the business e.g. enough changes to the operations/structure of the company, as to be wholly different to the previous registration.
THE CE MARK BULLETIN No. 2
INFORMATION ABOUT THE EC MEDICAL DEVICES DIRECTIVES BULLETIN No. 8
For more information, check out the links as below from MHRA:
In How we regulate
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