UK Medical Device PMS Requirements, Explained
Things have been happening in industry.
Firstly, I just want to say at the start of this that the guidance released on the indefinite acceptance of CE Marking in the UK does NOT apply to Medical Devices. Queue many sad faces…You can find the confirmation here - CE marking recognition for medical devices and in vitro diagnostics
Anyway, the draft strengthened post market surveillance requirements were released last week and everyone has been posting about this, here is more of a breakdown hopefully, but let’s keep this short-ish:
Here is the full document if you want to read it - The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023
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Key Takeaways 🔑
The PMS requirements will now apply to all devices. Regardless of risk class.
Periodic Safety Update Reports (PSURs) are only applicable to iia and above. Consistent with the EU MDR. Class IIb shall conduct PSUR within 1 year of being placed on the market or put into service and update the PSUR at least annually.
Reporting requirements are aligned with the EU MDR. Manufacturers can continue to use the MIR form. The timelines to reiterate are:
Serious incident involving a serious public health threat - no later than 2 days.
If there is a death or unanticipated serious deterioration in a person’s state of health - no later than 10 days.
Unless the above apply, no later than 15 days after the manufacturer becomes aware.
The government intends to lay this legislation this winter and it is expected to apply from mid-2024. Accompanying guidance will also be published.
General Overview & Summary
It’s good to see the MHRA defining how the PMS system should connect to the rest of the QMS. Throughout the document, it makes reference to the fact that PMS should result in updates to the following:
(i) the instructions for use and labelling of the device;
(ii) design and manufacturing information;
(iii) the required risk analysis;
(iv) the evaluation of clinical data referred to in regulations 9(2) and 23(2) for the purposes of confirming conformity with the relevant essential requirements;
(v) any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 2 or 3.
Main Objectives
Increased scope of devices that must comply with the new PMS requirements, this includes CE marked devices.
Detail of what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
Enhanced serious incident reporting obligations for manufacturers to support the 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
Definitions
Firstly, there are a few definitions that require some limelight:
Lifespan - this new phrase is not mentioned in the EU MDR or the UK MDR. It is defined as the lifetime of a device + the period that is reasonably foreseeable the device will remain in use
Life time of a device means the shelf life of a device plus the period the manufacturer expects the device to perform as intended
PMS period - beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner; and ending with the end of the lifespan of the last device if that device model that is put into service by the manufacturer or placed on the market whatever is later.
Devices in Scope
a device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42;
a device placed on the market in accordance with regulation 19C and classified as belonging to class I under Regulation (EU) 2017/745;
a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class I under regulation 7 (classification of general medical devices);
a device placed on the market in accordance with regulation 44ZB and classified as belonging to class A or B under Regulation (EU) 2017/746;
a device otherwise placed on the market or put into service in accordance with Part 4 that is not a device referred to in the lists in Annex II of Directive 98/79.
Post Market Surveillance Plan Requirements
The regulation specifies what shall go into a PMS plan, as below:
A PMS plan must be—
clear, organised and searchable, and (YES THIS MEANS ADOBE SEARCHABLE)
maintained for the PMS period of the device model.
The PMS Plan must include:
processes for the collection and assessment of the following information in relation to the device—
(i) information about serious incidents, other incidents and side-effects;
(ii) information about field safety corrective actions;
(iii) information for the purposes of identifying trends in incidents and if applicable, reporting those trends under regulation 44ZN (trend reporting);
(iv) feedback and complaints provided by users and suppliers of the device;
(v) information about user experience, including through patient and public engagement, where appropriate;
(vi) other information relevant to the post-market surveillance of the device, including information relating to similar devices available on the market and available outside Great Britain.
suitable indicators and threshold values to be used in the reassessment of the required risk analysis;
effective and appropriate processes to investigate complaints and analyse feedback and information about user experience;
processes to manage incidents and trends (whether or not they must be reported under regulation 44ZN (trend reporting)), including—
the statistical methodology to be used to determine a significant increase in the frequency or severity of incidents, and
in relation to a device placed on the market or put into service in accordance with Part 4, the statistical methodology to be used to determine a significant increase in expected erroneous results;
a process for communicating effectively with the Secretary of State, the approved body for the device (if there is one), the UK responsible person (if there is one), users and suppliers of the device;
processes that provide for how the manufacturer will comply with their obligations under this Part
a plan for any post-market clinical follow-up required under Part 2 or 3
the post-market surveillance report required by regulation 44ZL (post-market surveillance report) or the periodic safety update report required by regulation 44ZM (periodic safety update report).
Post Market Surveillance Report (PMSR) Requirements
The PMSR must include:
A summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan, and
(b) a description of any preventive or corrective action that has been taken in relation to the device and the reason for doing so.
A PMSR must be:
produced within 3 years of the device being placed on the market or put into service, whichever is sooner, and
updated by the manufacturer every 3 years until the end of the PMS period for the device model.