UK’s Draft Post-market Surveillance (PMS) Requirements Compared to the EU Regulation Requirements on PMS

By Beth Pugh, Karen Hill and Evangeline Loh

Background

As noted in a previous Regulatory Update, a draft Post-Market Surveillance statutory instrument (PMS SI) was laid in Parliament (Oct. 21,) to introduce new PMS requirements.

Comparison between PMS SI and EU regulations

This legislation appears to further align Great Britain’s (GB) PMS and vigilance requirements with the European (EU) regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)).

While much of the new GB PMS requirements are aligned with the EU regulations, there are some notable differences. This article discusses the PMS aspects, and our next feature expounds on vigilance.

Definitions in the PMS SI

Analogous to the new terms and definitions added by the EU MDR and IVDR, the following new terms and definitions have been introduced to the PMS SI:
 

• Lifetime of a device
  The shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended.
   
• PMS period
  The period beginning with the day on which the first device was put into service or placed on the market and ending with the end of the lifetime of the last device model that is placed on the market or put into service, whichever is later.
   
• Similar device
  A device that has the same intended purpose and is based on the same or similar technology.
   
• Required risk analysis
  The analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements.

PMS system in the PMS SI

The structure of the PMS System between the GB and EU are identical: PMS Plan, PMS Report (PMSR), and Periodic Safety Update Report (PSUR).

The requirements of the PMS System are similar, with the addition that the PMSR or PSUR must be updated for the PMS period of the device model, whereas the EU uses the phrase that it must be maintained for the lifetime of the device. Additionally, the PMS records must be retained in GB for the longer of the PMS periods or 15 years in the case of an implantable device and 10 years in the case of any other device.

The legislation requires the PMS Plan to consider user experience through patient and public engagement, if appropriate, this is not as explicitly stated in Annex III, 1.1 of the EU regulations.  

The PMSR in GB needs to be drafted within 3 years of being placed on the market or put into service and then updated at least every 3 years while the EU Regulations only state that they are updated when necessary.

Differences are noted for what has been proposed for the PSUR.

PSUR in the PMS SI

The PMS SI has specific information about how devices can be organized in a PSUR. A single PSUR for a category or group of devices is permitted only if the devices are covered by the same clinical evaluation report or performance evaluation report and the devices are similar and the manufacturer considers that the similarity between the devices justifies a single PSUR.

The timing to update the PSUR is identical to the EU, with the initial PSUR being required after one year for the higher-risk devices or two years for Class IIa devices after being placed on the market.  

The PSUR and each updated PSUR must be submitted to the Approved Body (AB), if applicable. If the device is Class III, implantable or Annex II List A/B, the AB must review the PSUR and issue a report.

Concluding remarks

PMS continues to be a critical topic.

After the PMS SI comes into force, the general PMS requirements in GB will more closely align with the EU requirements. However, as discussed, new requirements have been introduced to further safeguard public health.

Our next Regulatory Update will compare the vigilance requirements in the draft PMS SI with the EU regulations.