A recent Medical Devices Directive demands that accessories such as water purification units be treated as medical devices in their own right. This empowers the Medicines and Healthcare products Regulatory Agency (MHRA) with the right to seize and to remove unsafe products from manufacturers and to retain them as evidence if proceedings are taken.
The Department of Health report for patients, clinicians and healthcare managers entitled Safety First states: “Patient safety encompasses a range of errors and system failures associated with the delivery of patient care. This can include situations such as mistakes and delays in diagnosis, medication and treatment errors, problems with equipment, infections acquired in hospitals and accidents such as slips and falls.”
To address the issue of equipment safety, the Medical Devices Directive was issued by the European Parliament and Council. The conformance requirements apply to all Member States, which must implement them in their national legislations.
Even accessories to medical devices are encompassed by these requirements, including equipment such as water purification systems intended to provide supply for renal dialysis. The Medical Devices Directive (93/42/EEC amended by Directive 2007/47/EC) states that: “…accessories shall be treated as medical devices in their own right”. For example, such a device will be required to be classified under the Directive (Class IIb), be CE-marked and its compliance subject to the compulsory intervention of a notified body.
www.mhra.gov.uk