Scope of this ESSENTIAL
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This ESSENTIAL describes the regulatory requirements in Great Britain (England, Scotland, Wales), based on the - Medical Device Regulation 2002 (SI 2002 no.618) - EU Directive 93/42 - Guidance documents for medical devices, published by BEIS (Department for Business, Energy and Industrial Strategy)
UK adopted to the former EU Medical Device Directive. When Great Britain left the European Union (31-JAN-2020 - Exit Day), they did not adopt the newly published EU Medical Device Regulation.
In scope of this ESSENTIAL are Medical Products, Classes I, IIa, IIb, III. Not in scope of this CRF: - In-Vitro Diagnostica - Active Implantable Medical Devices'
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