Agency Priorities
This article was originally published in RAJ Devices
Executive Summary
UK MHRA publishes business plan
UK MHRA publishes business plan
Increasing postmarket surveillance of medical device companies, updating guidance documents and attending to the revision of the European Union (EU) Medical Devices Directive are some of the challenges facing the UK Medical and Healthcare products Regulatory Agency (MHRA), the agency announces in its business plan for 2006-07.
A major objective for the agency in 2006-07 is transposing the joint reclassification directive, Directive 2005/50/EC, into UK law1. The directive upgrades hip, shoulder, and knee joint replacements to class III (ie high risk) medical devices, which will lead to more rigorous regulation of these devices. The agency is planning to work with France, its partner in requesting this reclassification, and industry representatives to prepare pan-European guidance outlining what the directive specifically means for manufacturers and notified bodies.
With regard to surveillance, the MHRA is seeking to improve overall levels of member states' regulatory compliance activities. The UK agency, together with some of its EU counterparts, will implement a number of postmarket surveillance activities to achieve this. These include better sharing of information; greater coordination of activities; and more cooperation among different national authorities. In addition, the MHRA will have a lead role in developing guidance procedure for manufacturers of Class I medical devices to support ongoing efforts to make member states' postmarket surveillance more effective.
The business plan reports that the number of adverse incident reports received in respect of medical devices dropped by 11% in 2005-2006. However, the agency goes on to point out that the number of in-depth investigations it carried out on more serious adverse events rose to nearly 33% of the reports received. The agency plans to develop an improved system for risk assessment and to optimise the resources used in investigations. It will also encourage patients and the public to report adverse incidents of concern.
Enforcement
The MHRA says it has one of the largest medical device compliance programmes in the EU. Over the year, it expects to investigate more than 200 cases of alleged non-compliance reported to it, and to identify a further 250 itself as part of a pro-active enforcement programme.
The agency's inspections will target a number of specific areas, including, for example, the availability of devices over the internet. It also plans to run coordinated compliance exercises with other member states, so that it can build on expertise gained during a recent exercise involving counterfeit devices.
Notified bodies
The MHRA plans to audit all active UK notified bodies and conformity assessment bodies at least once a year to ensure that they continue to operate at an acceptable level. The agency has also published its corporate plan, for 2006-2010/112. In it, it refers to its “lively interest in the standards of authorisation throughout the EU” and says it will: ensure that rigorous standards are applied by UK notified bodies to ensure the safety and performance of devices; and press for consistently high standards throughout the EU in the operation of notified bodies for devices.
At the EU level, the MHRA continues to chair the European Notified Body Operations Group.
Benefits of the merger
It has been three years since the Medicines Control Agency and the Medical Devices Agency merged to form the MHRA. Kent Woods, the agency's chief executive, writes in his foreword to the business plan that there has been a considerable increase in collaboration between the two groups of staff since the merger, particularly since they came together in the same building. A prime example, Professor Woods writes, is in the MHRA's new role as the competent authority for human blood and blood components. Inspections of blood establishments are undertaken within the agency's medicines sector while the surveillance of adverse reactions and events is in the hands of devices staff, “allowing us to build on the expertise of existing groups of staff”. Other examples, he continues, include work on tissue engineering and nanotechnology, “the kinds of emerging technologies where our combined expertise is proving very helpful in the development of the European regulatory framework”.
Professor Woods notes that budgets are tight for the year, particularly for the medical devices aspects of the agency's work. Indeed, publication of the plan was delayed until there was agreement of what the funding would be for devices.
Medicines and devices
According to the business plan, once the organisation of the agency has been re-aligned, the MHRA will be able to develop a new model for monitoring the risk:benefit relationship of marketed medicines and medical devices. A cross-divisional Medicines and Devices Vigilance (MDV) Group will be established, to achieve closer coordination of work in pharmacovigilance and devices safety, and the communication of safety issues in these fields.
The creation of the MDV Group will not change the existing divisional structure, but will put in place mechanisms to allow for effective cross-divisional working in key business areas. The plan is that a “single Priorities Board within MDV will develop strategy to improve our knowledge of the risk-benefit relationship for medicines and medical devices and to raise awareness of risk-benefit amongst our stakeholders”.
References
1. Business Plan 2006-07, July 2006, Medicines and Healthcare products Regulatory Agency, www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2024165&ssTargetNodeId=387
2. Corporate Plan 2006-07 to 2010-11, Medicines and Healthcare products Regulatory Agency, www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2024165&ssTargetNodeId=387