Existing regulatory regime overview and delegated powers
The regulation of human medicines (including clinical trials of human medicines), veterinary medicines and medical devices falls within EU competence. The EU has legislated in each of these fields (taking clinical trials separately from the other regulatory aspects of human medicines) and created comprehensive regulatory regimes in each case. The comprehensive regimes, informed through the negotiation process by the UK Government, are established in EU legislation and have primarily been implemented in the UK by the following legislation:
The Human Medicines Regulations 2012 (SI 2012/1916)
The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)
The Veterinary Medicines Regulations 2013 (SI 2013/2033)
The Medical Devices Regulations 2002 (SI 2002/618)
	Each of the above sets of Regulations were made using section 2(2) of the ECA. The same delegated power has been used on a regular basis to update each set of Regulations, for example, the Human Medicines Regulations 2012 have been updated 11 times using section 2(2) of the ECA. Updates have taken place across these Regulations to reflect changes in EU Directives and updates to the EU regulatory systems.
	Now that the transition period has ended, section 2(2) of the ECA is no longer available for making changes to the regulatory regimes for human medicines, clinical trials of human medicines, or veterinary medicines through secondary legislation. In the absence of this delegated power, it is not possible to update the schemes except through primary legislation, even if those changes are relatively minor, or using powers in EUWA 2018 (in relation correcting deficiencies further to leaving the EU (power expires 2 years after the end of the transition period) or the NI protocol.
	The effect of the repeal of section 2(2) of the ECA on medical devices is slightly different. This is because medical devices legislation in the UK is made jointly under section 2(2) of the ECA and section 11 of the Consumer Protection Act 1987 ("the CPA"). Whilst section 11 of the CPA is not repealed (though it is being disapplied with respect to medical devices – see below) it cannot be relied on exclusively to update the regulatory framework for medical devices. This is because it only allows for provision to be made for the purpose of securing that devices are "safe", that is, that they do not create a risk of death or personal injury. This means that many aspects of the regulatory scheme cannot be updated using section 11 of the CPA, such as most technical requirements (particularly for lower risk devices), and obligations on manufacturers and others in the supply chain. This means that it will not be possible to update much of the regulatory framework for medical devices without primary legislation.
	Sections 2, 10 and 15 of the Act therefore provide critical but targeted delegated powers which enable specific features of the regulatory regimes for human medicines, clinical trials of human medicines, veterinary medicines and medical devices to be amended and supplemented. These delegated powers may only be exercised in relation to a finite list of matters specified on the face of the Act. The regulation maker have an overarching objective to satisfy before making these regulations, and as part of that assessment regard must be had to the safety and the availability of human or veterinary medicines or devices (as the case may be) and the likelihood of the UK being seen as a favorable place to develop and supply these products. Subject to two discrete exceptions. Further the regulation maker my only make regulations that may have an impact on safety if satisfied that the benefits of the proposed changes outweigh the risks. The powers may also only be exercised following public consultation.
	For two years after the end of the transition period, section 8 of the EUWA 2018 provides a power to address deficiencies arising from leaving the EU. Whilst under section 8C of the EUWA 2018, changes may be made to the existing regulatory regimes governing human medicines, veterinary medicines, and medical devices. Such changes are limited to matters that relate to giving effect to the Northern Ireland Protocol.