EU explains revised requirements for Class I manufacturers
This article was originally published in RAJ Devices
The European Commission has updated its guidance for manufacturers of Class I (low-risk) medical devices to help them comply with new legislative requirements that come into effect next year1.
The revised guidance is aimed at helping Class I manufacturers meet the requirements of national legislation transposing Directive 2007/47/EC, the amending directive which amends the Medical Devices Directive (Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Directive 90/385/EEC). National legislation transposing the requirements of Directive 2007/47/EC will come into force on 21 March 2010.
The updated document was endorsed by the commission’s Medical Devices Experts Group in December 20092; it replaces an earlier version of the guidance3.
Authorised representatives
New information in the document relates to new requirements concerning authorised representatives.
Device manufacturers who do not have a registered place of business in a European member state need to designate a single authorised representative in the European Union. This is to ensure that the authorities have a single person, authorised by the manufacturer, whom they can approach for matters relating to compliance issues. This designation, the guidance says, should be effective at least for all devices of the same model.
Clinical data evaluation, regulatory overlap & records
Although special clinical investigations are not usually required to establish data on performance and safety of side-effects of Class I devices, the guidance states that evaluation of existing clinical data must follow a “defined and methodologically sound” procedure.
It includes information on the overlap of the amended MDD with the Personal Protective Equipment Directive and the Machinery Directive.
Regarding records maintenance, the guidance notes that manufacturers (or their designated authorised representatives) must hold documentation for at least five years after the product has been manufactured.
Labelling, vigilance and PMS
Device manufacturers are responsible for providing the labelling and instructions for use information about their products.
In the light of technical progress in information technology and medical devices, the guidance notes that a process should be developed to allow this information to become available “by other means” – presumably electronic, as opposed to paper – also.
In the area of vigilance, the guidance points out that Directive 2007/47/EEC will make it a requirement for sponsors to notify all relevant competent authorities of adverse incidents occurring as part of a clinical investigation. It adds that any clinical evaluation and its documentation must be actively updated with data from postmarket surveillance.
References
1. European Commission, Guidance Notes for Manufacturers of Class I Medical Devices (Rev. 1_2009-06), Posted on 21 December 2009, http://ec.europa.eu/enterprise/sectors/medical-devices/files/guide-stds-directives/notes-for-manufacturers-class1-09_en.pdf
2. European Commission, Medical Devices: Consensus Statements Index, Page updated 21 December 2009, http://ec.europa.eu/enterprise/sectors/medical-devices/documents/consensus-statements/index_en.htm
3. European Commission, Guidance Notes for Manufacturers of Class I Medical Devices (Rev. 0_2007-09), December 2007, http://ec.europa.eu/enterprise/sectors/medical-devices/files/guide-stds-directives/notes-for-manufactures-class1-md_en.pdf