i Regulatory framework
The regulatory framework for medicinal products in Ireland is based on Directive 2001/ 83/EC on the Community code relating to medicinal products for human use (as amended) (the Community Code). This was implemented in Ireland by the Irish Medicines Board Act 1995 (as amended) (IMB Act) and domestic regulations, most notably the Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007) (as amended) (Marketing Regulations).
The regulatory framework for medical devices in Ireland is based on the following directives that have been transposed into Irish law: Directive 93/42/EEC concerning medical devices, Directive 90/385/EEC on active implantable medical devices (as amended) and Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive) (as amended). National legislation transposing those Directives (as amended) include the European Communities (Medical Devices) Regulations 1994 (SI 252/1994) (as amended in 2001, 2002 and 2009), the European Communities (Active Implantable Medical Devices) Regulations 1994 (SI 253/1994) (as amended in 2009), the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (SI 304/2001) (as amended in 2012), the European Communities (Medical Devices) (Reclassification of Breast Implants) Regulations (SI 358/2003) 2003, the European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 (SI 554/2003) and the European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 (SI 92/2007) (collectively, the Medical Devices Legislation). The existing Medical Devices Legislation is due to be overhauled when the new EU Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices (which formally entered into force at the end of May 2017) come into effect - 2020 for medical devices and 2022 for in vitro diagnostic medical devices. These two Regulations represent a significant development and updating of the existing regulatory system for medical devices in Europe and will replace the original EU Directives, which have been in place for over 25 years.
ii Regulatory authorities
The Health Products Regulatory Authority (HPRA; formerly the IMB)2 is the competent authority responsible for regulating medicinal products, medical devices, cosmetics and other health products in Ireland. The National Standards Authority of Ireland (NSAI) is the notified body in Ireland designated by the HPRA to carry out conformity assessment procedures to ensure compliance with the Medical Devices Legislation. The HPRA's main areas of responsibility are:
ensuring the quality, safety and efficacy of medicinal products (including veterinary medicinal products) available in Ireland, participating in systems designed to do so throughout the European Union, and monitoring the quality of medicinal products and their manufacturing and distribution processes; acting as the competent authority for the implementation of EU and national legislation relating to blood, blood components, tissues, cells and medical...