To better understand the implications of proposed Post Market Surveillance (PMS) to manufacturers of medical devices, the MHRA would like to be provided with data on firms’ expected cost of compliance with PMS regulations so far. This survey covers total costs of setting up a PMS system across an organisation, and the cost of maintaining a PMS.
This firm level data on costs will be collected, averaged and extrapolated to produce an estimate of what the costs of PMS compliance are across the medical technology sector. This data will be used to write the impact assessment for proposed Post Market Surveillance changes, which will help the MHRA understand what the costs of proposed PMS changes are. This assessment will be published, but company data will be anonymised. Questions about your organisation have been set up to reduce the risk of identifying your organisation as much as possible, while still providing necessary information.
For cost data questions, please provide your best available estimate as a single value for these questions. There will be opportunity at the end of the survey to provide additional detail if you need to. Questions asking for costs relate to the costs incurred on devices your organisation manufactures that are supplied to Great Britain.
The deadline for responses is Wednesday 17 May.
The privacy notice for this survey can be found here.
This is a survey being conducted by the MHRA. BIVDA will not be inputting as the requested information is specific to each organisation, and BIVDA accepts no responsibility for the contents. We encourage BIVDA members to contribute to this survey as accurately as possible to ensure a complete picture of possible impact.
If you have any questions, please contact Ashleigh.