What changes does the upgrade from observer to full member of the RAC entail?

The MHRA’s promotion from observer to full member of the RAC (Regulatory Authority Council) has three key practical implications:

  1. Earlier identification of risks – the agency will gain access to audit data from over 7,000 manufacturing sites worldwide, enabling it to detect signs of non- compliance more quickly.
  2. Enhanced post-market surveillance – information from MDSAP audits is to feed into the UK’s post-market surveillance (PMS) system, complementing national incident reporting mechanisms.
  3. Reduction in duplication of inspections – greater involvement in the programme is intended to promote international reliance between comparable regulators, which for manufacturers means fewer overlapping audits.

The MHRA emphasises, however, that the details of MDSAP implementation within the UK regulatory framework are still under review; the agency states that specific requirements for the UK market will be maintained regardless of the level of
integration with the programme. It is worth noting that the MHRA is not a new participant in this initiative: the agency has been involved in the development of the MDSAP since the programme’s early stages through the International Medical Device
Regulators Forum (IMDRF), and this latest announcement is a natural continuation of that collaboration, not its beginning.

What does this mean for manufacturers operating in the UK
market?

For Regulatory Affairs departments monitoring the UK market, this has one specific practical implication: an MDSAP certificate, if your organisation holds one or plans to obtain one, may in the near future gain additional value in the context of compliance
with the UK MDR 2002 as well. We recommend keeping an eye on further announcements from the MHRA regarding the timetable and scope of integration.

Link to source: MHRA information from the Kioto forum