UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
uses a UK Notified Body for mandatory third-party conformity assessment for purposes of the North- ern Ireland market, the UKNI mark must be applied together with the CE mark. Medical devices are classified based on the level of risk associated with use. Each risk class has its own conformity assessment route. A UK Approved Body may issue a UKCA certificate but is not able to issue CE certificates save for “CE UKNI” purposes valid only in Northern Ireland. Low-risk Class I medical devices do not require third- party conformity assessment. For all devices, once the relevant assessment has been completed suc- cessfully, the manufacturer may place a UKCA mark on their medical device and put it on the market in Great Britain. All devices placed on the Great Britain or Northern Ireland markets must be registered with the MHRA, which will only accept registration by UK-based enti- ties. Therefore, non-UK-based manufacturers must appoint a Responsible Person established in the UK. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal Products The HMRs state that a person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product, or a medicinal product, other than in accord- ance with the terms of an MA. However, there are exceptions whereby a product can be placed on the market without an MA. These exceptions include so- called “named-patient supply” where the medicinal product is: • supplied in response to an unsolicited order; • manufactured and assembled in accordance with the specification of a person who is authorised to prescribe; and • for use by a patient for whose treatment that person is directly responsible in order to fulfil the special clinical needs of that patient. The remaining conditions set out in the HMRs must also be met, including that no advertisement is issued in relation to the product.
The Early Access to Medicines Scheme (EAMS) is a scheme operated by MHRA that allows patients with life threatening or seriously debilitating conditions to access medicinal products to treat those conditions, which are either not authorised or not authorised for that use. Products supplied through EAMS must first be granted a Promising Innovative Medicine (PIM) designation and then be the subject of an EAMS Sci- entific Opinion, which remains in place for one year or until an appropriate MA is granted. EAMS medicines must be supplied to the NHS at no cost until an MA is granted. Medical Devices In relation to medical devices, it is also a requirement that all devices placed on the market must have a UKCA or EU CE mark. However, this is not a require- ment for devices that are custom-made for individual patients. Custom-made medical devices are defined as devices manufactured specifically in accordance with a duly qualified medical practitioner’s written prescription that gives specific design characteris- tics, under their responsibility, and is intended for the sole use of a particular patient. The manufacturer of a custom-made medical device must meet the require- ments of the UK Medical Devices Regulations that relate to custom-made devices. The MHRA may also approve exceptional use of a non-compliant device on humanitarian grounds. These devices do not need a UKCA mark. A manu- facturer can apply to the MHRA to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. The same provision may be made for cus- tom-made devices that have not complied with the standard conformity assessment procedure. 3.6 Ongoing Obligations Imposed by Marketing Authorisations MA holders must operate a pharmacovigilance sys- tem to monitor the safety of their medicinal product, and to detect any change to the risk-benefit balance. They must: • have an appropriately qualified person responsi- ble for pharmacovigilance (QPPV) located in the EEA (however, where this person does not reside
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