Ensuring efficient implementation of EU device regulations is a key activity the UK’s Medicines and Healthcare products Regulatory Agency has tasked for itself over the next year, according to a new business plan.
The plan is part of a five-year strategy to promote effective regulation for devices and drugs and further develop the National Institute for Biological Standards and Control and the Clinical Practice Research Datalink.
Specific device-related goals in the 2015-16 plan include collaborating with international agencies, such as the International Medical Device Regulators Forum, to harmonize global regulatory standards. Part of this goal is clarifying the European position on implementing elements of IMDRF’s medical device single audit program by the end of the third quarter. Implementing the MDSAP program in the EU has proven challenging because every participant must have confidentiality agreements with every other player. Agreements for each of the 28 nations would need to be negotiated individually.
The plan is part of thee MHRA’s plan to revise its medical device funding model. According to the business plan, funding for device regulation is half the level it was in 2003 in real terms. That comes even as adverse event reporting has increased more than 50 percent since 2009. Over the next year, the plan calls for about U.S. $14.3 million in funding and investment in efficiencies from the Department of Health.