February 22nd, 2021
The ABPI and BHBIA have updated their joint Guidance notes on collecting adverse events, product complaints and special reporting situations during market research.
Adverse event reporting for medical devices is now required.
This means that the same requirements for AE/PC/SRS reporting for medicinal products will be extended to medical devices.
Previously the Guidance Notes simply suggested that "for information about AE/PC/SRSs in relation to medical devices, please contact the company commissioning the market research”.
The changes include:
- Extending sections 1.2 and 1.3 on scope to include medical devices, associated definitions, and references;
- Adding in references to devices throughout the Guidance;
- Updating the list of legislation, section 1.4;
- Option given to select GB or NI for the reporting form when recording AEs/PCs/SRSs.
The update has been prompted by the recently passed UK Medicines and Medical Devices Act 2021 which requires more stringent safety reporting. The UK law will be followed in the EU by the Medical Devices Regulation which comes in to force on 26 May 2021.
Whilst we strongly recommend that all members put the guidance in to effect as soon as practical, the BHBIA (which requires its members to adhere to the guidance requirements) will allow until 26 May 2021 for members to have fully compliant policies and processes in place. However please note the UK Medicines and Medical Devices Act 2021 is now in force.
To explain and illustrate the impact of the updated guidance the BHBIA and the ABPI are holding a joint webinar for members of both organisations:
- Thursday 18 March 2021 - 12.30-1.30pm
- Will include time for Q&A with the ABPI and BHBIA presenters
- Free of charge to full BHBIA members
It’s suitable for anyone engaged in recording or
monitoring AE/PC/SRSs from market research work whether on the company or
agency side but it is particularly important that those in device manufacturers
keep up to date with the new requirements.
Book your place here (BHBIA and ABPI members only)