The Medical Devices (Amendment) Regulations 2012
These Regulations amend the Medical Devices Regulations 2002 (S.I.2002/618), as most recently amended by the Medical Devices (Amendment) Regulations 2008 (S.I.2008/375) (“the 2008 Regulations”). The 2008 Regulations implement Directive 2007/47/EC of the European Parliament and of the Council (OJ No.L.247, 21.09.2007, p.21).