EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations are made in order to address failures of retained EU Law to operate effectively and to correct other deficiencies.
Schedule 1 makes amendments to the Medical Devices Regulations 2002 (S.I. 2002/618) (as they apply in Great Britain) to correct a number of deficiencies. In particular, this Schedule makes textual amendments to references to EU legislation or EU bodies so that those references are to domestic legislation or to domestic UK based bodies.
Schedule 2 makes amendments to a number of pieces of EU tertiary legislation, retained under the EU Withdrawal Act 2108, which relate to medical devices to ensure that the legislation operates effectively in the context of UK Medical Devices regulation (as it applies in Great Britain). In particular, this Schedule makes amendments to four pieces of EU tertiary legislation to remove processes and procedures which are not relevant to the operation of that legislation in a domestic context and makes textual amendments to references to EU legislation or EU bodies so that those are references to domestic legislation or to domestic UK based bodies.
An impact assessment has not been produced for this instrument as no, or no significant, impact on private, public or voluntary sectors is foreseen.