§ Mr. Gordon PrenticeTo ask the Secretary of State for Health with what frequency the premises of manufacturers of medical devices are visited and inspected by the Medical Services Agency. [2392]
§ Mr. HoramResponsibility for this matter has been delegated to the Medical Devices Agency under its chief executive Mr. Alan Kent. I have asked him to reply to the hon. Member.
Letter from Alan Kent to Mr. Gordon Prentice, dated 30 November 1995:
I am writing to you in response to your Parliamentary Question about the frequency at which the premises of manufacturers of medical devices are visited and inspected by the Medical Devices Agency.Manufacturers of medical devices applying for inclusion in the Register of Approved Manufacturers are assessed before registration. The aim is to carry out further assessments every 3 years when the company seeks re-registration. Additional special audits or visits may be conducted when there is reason to suspect that the company no longer satisfies the registration requirements.New Statutory requirements, harmonised within the European Union through Directives, are replacing progressively the voluntary Manufacturer Registration Scheme (MRS). Since 1 January 1995 some manufacturers have chosen to use independent certification bodies, that is Notified Bodies, to assess their quality assurance systems and confirm they are complying with the requirement of the Directives. Through mutual recognition agreements, MDA has been able to use Notified Body 862W assessments as a basis of registration to the MRS. The Manufacturer Registration Scheme will be discontinued in mid-1998 when the regulations supporting the Directives are fully implemented.I hope the above is helpful.