The new Draft Statutory Instrument for Medical Devices (Post Market Surveillance) has been published on the WTO website this afternoon (SI/SR Template (wto.org)).
Our first initial review for IVDs from a quick read this afternoon is the following:
- Post market surveillance is required for the whole of the “PMS period” – this is the time from the device first being placed on market, until the end of life of the last device placed on market.
- The Vigilance reporting timelines are the same as IVDR – 15 days for serious incident, 2 days for serious public health threats & 10 days for death or unanticipated serious deterioration in a person’s state of health.
- Field Safety Notices, where required, have to be provided to all known users of the device and published on the manufacturer’s website
- Post market surveillance plans are required
- Post market surveillance reports are required every 3 years for General IVDs (or Class A or B devices under IVDR)
- Periodic Safety Update Reports are required every year for Annex II IVDs (or Class C or D devices under IVDR) and have to be provided to approved bodies for review.
- PMS documentation has similar requirements to the IVDR and has to be retained for the “PMS period” or 10 years whichever is longer.
Overall, our first impression is that this is very similar to the requirements in the IVDR which is very welcome news for the industry.