Medical Device Technology Forum

This proposal has been developed in part as a result of our consultation last year on the Agency's five-year strategy, where a number of consultation respondents encouraged us to take a more proactive approach to considering the impact of emerging technologies in the devices sector, and is separate from the New Technology Forum for medicines that was set up in 2007. In the first instance this Forum will meet yearly, but it is our intention that this will increase to twice a year. The aims of the Medical Device Technology Forum are:

• to ensure that all novel technologies are appropriately monitored and regulated, not only to optimise the safety of patients and users, but also to minimise unnecessary delays to product marketing due to an unclear regulatory process. This first point may result in the production of guidelines for the industry or user, new standards being proposed or, where appropriate, to influence future changes to legislation
• to provide an important part of ensuring that those working at the MHRA are kept up to date with these novel technologies so that the Agency can maintain its expertise as technology in healthcare develops
• to perform the important task of bringing together industry, regulators, users and scientists to ensure a high level of interaction and awareness regarding these new technologies, their potential uses, and any potential implications for how they are most effectively regulated, both protecting health and avoiding unnecessary deterrents and obstacles to manufacturers in exploiting new technologies for the benefit of patients.

On the 9 June 2008 the Medical Device Technology Forum's Topic Selection Panel held its inaugural meeting. This consisted of members from MHRA, Industry, Clinical Medicine and from scientific research backgrounds. The outcome was that the first Forum, to be held on the 27 November 2008, will be on Human Tissue Engineered Products and their regulatory status. Minutes of the Topic Selection Panel meeting will be made available once they have been ratified. Items discussed included non invasive blood pressure monitoring, medical device user testing methodologies, microspheres, market entry barriers for urology and stoma care products, orthopaedic implant load restrictions, robotic assisted surgery, clarification of the MHRA position on medical software, and the introduction of new technologies into NHS Trusts.

Invitation for proposals for topics for discussion
The Forums will be held twice a year, and will bring together some 30 scientists, industry experts, clinicians, users and lay people to discuss a specific topic selected by the Topic Selection Panel. They will look at different aspects of the technology - scientific, regulatory and clinical. We are inviting you to put forward proposals for topics to be discussed; these may include technologies coming to the market in the future whose regulation may be unclear and disadvantageous to industry, or whose safety may be questioned due to the advanced technology used, or topics that address any other potential regulatory barrier to bringing future medical device technologies to market. One of the topics suggested will be selected for in-depth discussion.

A ten-member topic selection panel, drawn from the MHRA’s Committee on the Safety of Devices, its Registry of Medical Device Experts, Notified Bodies and industry, will advise on the selection of topics to be addressed and on potential speakers at the Forum. Examples of subjects that may be of interest might include acellular tissues, such as amniotic membrane, the use of robotics in minimally invasive surgery and nanotechnology, and novel material usage in implants.

Please send your suggestions for topics to:

Dr Christopher Brittain
Room 5/2 E
Market Towers
1 Nine Elms Lane London SW8 5NQ
E-mail: christopher.brittain@mhra.gsi.gov.uk