The UK government has informed Medilink that they have notified the World Trade Organisation and its members of the draft Statutory Instrument (SI) the UK government now intend to lay in Parliament this winter regarding future PMS requirements for the UK market.
The draft PMS Statutory Instrument includes:
- Detail of what must be included as part of a PMS system, including methods for collecting PMS data to support improved capture of PMS data and harmonisation across manufacturers.
- Enhanced serious incident reporting obligations for manufacturers to support detection of safety issues sooner.
- More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.
It is therefore likely that the GB requirements will be similar to those in Europe under the Medical Device Regulation (2017/745).
Regarding timelines, it is expected the new PMS regulations will apply from mid-2024.
If you have any questions are require support, contact [email protected]
Patrick Trotter PhD, MBA(Techmgmt)
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