Regulation

The regulatory process for new healthcare technologies is complex. It is important to understand the regulatory framework and how it might apply to your technology as you can collect data and implement processes to comply with that framework during the course of your project.

There is a legal requirement to meet the conditions imposed by the regulators before any new technology can be made available to the public. There are different regulatory regimes, with different requirements, across different territories and there is a cost in both time and money in acquiring approvals to market products in those territories;  picking the right territory to target is vital. The most commonly targeted markets are the UK/EEA and the US for which the relevant agencies are the MHRA/EMA and FDA respectively. The choice of territory is usually driven by the viability of the market and the ease of meeting the regulatory requirements for a given technology.

Regardless of territory the regulatory process requires presenting evidence as to the safety and (sometimes) efficacy of the new technology, but the specifics of this process can vary dramatically depending on the type of technology under consideration. The required process is typically proportionate to the level of risk involved in the use of the device (for both patient and operator) and there is an order of magnitude difference in both cost and time between collecting suitable evidence for the least risky devices, such as a simple bandage, and the most such as an implantable pacemaker.

The novel nature of research means that there will not always be a clearly defined regulatory pathway for novel technologies. By considering potential pathways and engaging with regulators early you can identify how your technology might fit with existing pathways and if it doesn’t fit it will enable you to work with the regulators to develop an appropriate pathway. The regulators commonly have specific offices or teams that are used to dealing with early stage enquiries and will often provide this advice free of charge.

By understanding the regulatory pathway for your technology, you can ensure you conduct your research in a way that is consistent with that pathway. If you think your human or animal research results might be used as part of evidence submission to a regulator in the future you should check whether the methodology and results will be compliant with the regulator’s requirements. Discussions with the regulator upfront will establish what testing and/or validation is required during the pathway to impact and may avoid unnecessary experiments or repeating experiments which were not performed to criteria required for regulation At the end of your EPSRC project you will likely have collected only a small proportion of the data and evidence required to fulfil regulatory requirements, but having this evidence and being able to demonstrate an understanding of the regulatory requirements for your technology will make it a more appealing prospect for subsequent funding.

Questions to Consider

  • Which territories might you want to market your technology in?
  • Who is the relevant regulator?
  • Does that regulator have a clear pathway for your type of technology?
  • Is your technology a medical device, a medicinal product or an IVD?
  • What risk classification might your product have?
  • Given the above, how long is it likely to take to complete the regulatory process and how much will it cost?

Resources to Request

As part of your proposal you should consider requesting resources to:

  • Undertake appropriate training to develop an understanding of the regulatory process. This could include a secondment or discipline hop.
  • Employ a regulatory expert on the project.
  • Resources to facilitate meetings with the regulator(s) such as travel or meeting costs.

Further Information

  1. MHRA Innovation Office – provides a single point of access to expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes develop innovative medicines, medical devices or novel manufacturing processes for the UK/EU market. 
  2. MRC Regulatory Support Centre - Support and guidance for those conducting research with human participants, their tissues or data. 
  3. FDA Center for Devices and Radiological Health – provides advice and guidance on the regulatory process for Medical Devices for the US market.   
  4. FDA Center for Disease Evaluation and Research – provides advice and guidance on the regulatory process for Drugs and Biological Therapeutics  for the US market. 
  5. European Medicines Agency  - Provides advice and guidance on the regulatory process for the EU market. 

 

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