Medical Device Technology Forum

This proposal has been developed in part as a result of a consultation in 2008 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.

Medical device registries
One of the aims of the Medical Device Technology Forum (MDTF) is to ensure that all novel technologies are appropriately monitored and regulated to optimise the safety of patients and users.

The Topic Selection Group decided that the issue of Medical Device Registries was within the remit of the MDTF since data from this source is important in terms of device post-market surveillance and therefore an appropriate topic to be considered by the Forum.

It is acknowledged that the long-term safety or efficacy of some medical devices cannot be proven before more widespread clinical use. To ensure the safety of these devices, and their associated procedures, the use of registers has been considered as a mechanism to provide an early identification of emerging problems as well as useful information on long-term safety, performance and reliability.

Registers have the potential to provide an excellent source of data for clinicians, manufacturers and regulators.

Report on Registers (170Kb)

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.