MDA Publication Scheme

Documents available in compliance with UK Freedom of Information Act

The UK Medical Devices Agency has introduced the `MDA Publication Scheme', in the form of a guide listing the classes and types of information routinely published by the agency (see Table 1)¹. The listing is posted on the MDA website with links to enable downloading of those papers and publications that are available free of charge. Documents and printed publications can also be ordered from MDA. The scheme has been set up to comply with Section 19 of the Freedom of Information Act of 2000² and feedback is requested via the MDA Freedom of Information officer.

Table 1. MDA Publication Scheme, United Kingdom

Class of information	Description
About MDA	Description of the MDA's work, outlining its aim, roles and responsibilities and resources available.
Adverse incidents reporting	Explains the procedure for reporting adverse incidents online, by mail/fax, e-mail or telephone, with downloadable versions of all forms.
Agency structure	Chart of MDA's business sections and brief descriptions of their roles and responsibilities.
Corporate publications	Publications concerning the MDA's core roles and responsibilities.
Current externally advertised vacancies	Listing of all externally advertised staff vacancies.
Device evaluation - publications/guidance	Documents to evaluate devices and equipment used for pathology, diagnostic imaging, life-support and disability e.g. assessments, reviews, reports. These offer user information as well as essential information to those involved in the design, production, testing and maintenance of devices.
Education and events	Details regarding MDA events and seminars.
Enforcement - publications/guidance	Documents outlining the measures at the MDA's disposal for enforcing the provisions of the medical device regulations, guidance to manufacturers on their rights in the event of a compliance inspection and the form such inspections take.
Guide to contacts in the MDA	Regularly updated list with addresses, names, fax, telephone numbers and e-mail addresses.
Information asset register	List of information sources held by government departments, concentrating on unpublished sources.
IVD regulations - publications/guidance	Guidance documents for manufacturers and device users on issues arising from the transposition into UK law of the In Vitro Diagnostics Directive^3, including a background note and registration information.
MDA device safety - publications/guidance	Documents/information including Device Bulletins, general advice on medical devices, `One Liners' and in-depth coverage of important and ongoing medical device issues.
MDA safety warnings	Documents warning of problems with medical devices and actions to be taken e.g. Device Alerts.
Regulatory affairs - publications/guidance	Documents giving guidance to manufacturers and users of medical devices on issues arising from the translation into UK law of the Medical Devices Directive . This includes identification of relevant statutory instruments and instructions for authorised representatives of foreign manufacturers.
Relevant legislation - publications/guidance	Documents/information giving guidance to manufacturers and users of medical devices on the interpretation of legislation in respect of the EU's Medical Devices Directive^4.
Vigilance publications/guidance	Documents for manufacturers and device users including guidelines on the vigilance system's requirements, reporting procedures, and post-reporting action. Documents also describe what the competent authority does when a report is received.

References

1. MDA Publication Scheme, last modified 4 December 2002, www.medical-devices.gov.uk

2. Freedom of Information Act, 2000, available from The Stationery Office Limited (ISBN 0 10 543600 3), also via www.hmso.gov.uk

3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ , 1998, L331 , 1-37

4. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ, 1993, L169, 1-43