Medical Virology SAC

Medical virology is the study of viruses and the human diseases caused by them. Specialists in medical virology help in the investigation and treatment of patients suspected of having a viral infection.

Chair: Professor Richard Tedder

Committee Members

 

European Directive On In-Vitro Diagnostic Medical Devices
In common with other laboratory disciplines, virology has already felt the considerable impact of the requirement for CE marking for assays and reagents that has resulted in the withdrawal of some commercial products. Together with colleagues in the UK Clinical Virology Network and the Health Protection Agency, committee members prepared estimates of the serious consequences that the interpretation of ‘health institution’ in this Directive by the UK Medicines and Healthcare products Regulatory Agency (MHRA) would have. Diagnostic virology services are frequently requested for samples on a referral basis.

In 2012 amendments were proposed to the directive and committee members from a range of the College's Specialty Advisory Committees responded swiftly to a request from the European Offices of the European policy office of the NHS Confederation to ensure that the voice of the medical professionals was taken into account. Subsequent developments are being monitored by College representatives.

Information on the Directive (Directive 98/79/EC of the EUropean Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices) is to be found on the website of the European Commission. Policies and information on revisions are to be found here:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm

whilst the legal framework and detail of revisions to the directive is to be found here: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:en:NOT