Properly ensuring the safety and efficacy of a medical device means regulation throughout its lifecycle, including post-market surveillance rules to monitor and evaluate a medical device once it has entered the market.
The Medicines and Healthcare Products Regulatory Agency is responsible for regulating the UK medical devices market. On 9 January 2024, the agency produced a roadmap towards the future regulatory framework for medical devices, which sets out intended timescales for the delivery of future core regulations. This includes laying new draft regulations in parliament and publishing draft guidance in respect of post market surveillance (PMS) in early-mid 2024, with the regulations set to be in force late 2024.
This article highlights how the UK Medical Devices Regulations 2002 is changing and what this means for manufacturers. We also investigate the key differences between the EU and UK law that manufacturers need to consider.
PMS refers to ongoing monitoring and assessment of a medical device after it has been placed in the market. It is essentially a set of activities conducted by the manufacturer, to collect and evaluate feedback gained from the medical device. It also identifies whether any action is needed to ensure that same device continues to be safe and well-performing.
On 26 July 2023, the World Trade Organisation published notification of draft UK Post-market Surveillance Requirements Statutory Instrument (PMS SI), which included a link to the draft statutory instrument.
The draft PMS SI will amend the current UK Medical Devices Regulations 2002, to introduce more comprehensive PMS requirements for medical devices placed on the market in England, Wales and Scotland. The comment period for the World Trade Organisation notification closed on 25 September 2023 and the government is reviewing the responses and intends for PMS SI to be laid this year. Accompanying guidance will also be published.
As it stands, the UK Medical Devices Regulations sets out a general principle of PMS obligations for a manufacturer to continue to monitor its performance. However, the detail surrounding how they conduct their PMS and vigilance obligations is not covered by the current legislation. Instead, it is covered by non-binding guidance, leading to inconsistencies in the approach by manufacturers in relation to ongoing monitoring and assessment.
The PMS SI is intended to introduce clearer PMS requirements, many of which are aligned with the European Medical Devices Regulation 2017/45 and In Vitro Diagnostic Medical Device Regulation 2017/746. However, there are subtle differences which mean that the requirements in Great Britain will not be the same as in the European Union. Manufacturers must be alive to these differences and ensure the scope of their PMS activities meets the requirements of the new regulations.
As noted in the World Trade Organisation notification, key changes include:
Whilst the below list does not comprise of an exhaustive list, it does highlight three key differences between the EU and UK law.
Under current EU law, a manufacturer of a device must retain the technical documentation relating to that device for 10 years. This starts from the date when the last device is placed on the market in the EU, or 15 years if the device is an implantable device.
The UK PMS SI takes a difference approach, requiring a manufacturer of a device to retain the technical documentation relating to that device until the later of:
ACTION: In reality, the lifespan of a device will almost always exceed the minimum retention period of 10-15 years, so this will tend to be the period for which PMS documentation must bet retained. To ensure that they are compliant, manufacturers must review their devices in line with the definition of ‘lifespan’ in the PMS SI and determine what they consider its lifespan to be.
Under current EU law, a manufacturer does not generally need to report a field safety corrective action in relation to a device outside of the EU. Under the UK PMS SI, where a field safety corrective action is undertaken outside of Great Britain in relation to a device which has also been placed on the market in Great Britain, the manufacturer must notify the regulator.
In terms of field safety notices, the requirements are broadly the same, save that manufacturers must publish the field safety notice on their website and take all reasonable steps to ensure that the notice is sent to all known device users, rather than entering it onto a centralised system.
ACTION: Review contractual arrangements in respect of field safety corrective action reporting and processes for notification to the regulator.
The GB PMS SI definitions of ‘preventative action’, ‘incident’ and ‘serious incident’, whilst predominantly the same, are broader, potentially expanding the types of actions and incidents that will captured by the definition.
ACTION: Consider the EU and GB definitions separately to determine whether a particular event is captured by UK PMS SI and not EU.
Given the regulatory changes on the Horizon, it would be prudent for manufacturers to proactively review their systems and procedures ahead of the bringing into force of new legal requirements in respect of PMS.
For more information, please contact Ian Manners.
