Review of Documentation on Post-Market Surveillance by Surveillance Authorities.
PMS is a central element of the MDR (Medical Device Regulation) and MepV (Medical Devices Ordinance). It obliges manufacturers to systematically collect, evaluate and respond to data on the safety and performance of their products on the market. However, the results of Swissmedic's focus campaign reveal widespread shortcomings in implementation, including in documentation, reporting structure and links to quality management.
In this article we will:
- explain key terms such as PMS, vigilance, PMCF and CAPA,
- summarise the main results of the official test,
- and provide recommendations for a practical and regulatory clean implementation.
The System of Post-Market Surveillance – Terms and Processes
The basis for post-market surveillance can be found in Article 83 of the MDR. It stipulates that manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system for each product.
The intent behind this is the active and systematic surveillance with regard to the safety and effect of any marketed products. The MDR lists a number relevant purposes of PMS as well as it defines the form and scope of the documentation of PMS.
Furthermore, the closely related vigilance should be mentioned. Vigilance subsumes a number of precesses which aim to detect, classify and avoid adverse events or serious incidents . Adverse events are classified according to their severity, i.e. the extent of harm to users or third parties. The more serious the adverse event, the faster manufacturers are required to report it to the competent authority. A robust PMS system is essential to enable this.
The purpose of vigilance and the accompanying manufacturer obligations is, of course, patient protection. In particular, through so-called corrective actions (CAPA for corrective and preventive actions). Manufacturers are obliged to recognise the need for CAPAs (obligation resulting from §83 and §84), as well as to initiate necessary processes to take effective corrective actions.
Post-Market Surveillance and vigilance should not be confused with market surveillance. The latter consists of random checks and targeted investigations – as carried out by swissmedic – and is conducted under the direction and responsibility of the authorities. PMS and vigilance are conducted under the direction and responsibility of the manufacturers.
Background and Aim of the Study
Swissmedic, the Swiss surveillance authoritie, is now reporting on a market surveillance measure: as part of its market surveillance, 30 devices with CE certification under the old legislation (under MDD or AIMDD) were tested there. The investigation examined whether PMS systems that complied with the regulations had been established for these products and whether the required safety reports (PSURs – Periodic Safety Update Reports) had been prepared completely and correctly in accordance with Article 86 MDR and Article 59 MepV.
The aim of the review was not only a formal check of the documentation, but in particular an assessment of whether manufacturers actually implement the post-market surveillance obligations – i.e. identify and assess risks and take appropriate action.
Key Findings
The analysis showed significant deficits:
- Non-conformities were found in two-thirds of the cases (20 out of 30 products).
- In particular, PMS plans were often missing completely (11 products) or were incomplete.
- In eight cases, the PSUR did not comply with the previously defined PMS plan.
- Other typical deficiencies concerned the absence of key content in the safety report:
- Sales volumes and estimated patient numbers
- Information on corrective and preventive actions (CAPAs)
- Results from Post-Market Clinical Follow-up (PMCF)
- Conclusions on the risk-benefit assessment
It was also striking that 28 of the 30 products tested came from foreign manufacturers. In these cases, the authorised representative (AR/REP) was the direct point of contact for the authority.
Relevance for Manufacturers and Authorised Representatives
The results show that PMS and PSUR are in many cases not systematically implemented or adequately documented. The regulatory requirements are clear: According to MDR Article 83 ff., a manufacturer must set up a PMS system for each product that takes into account all available field data and actively contributes to improving product safety.
The PSUR is mandatory for devices in classes IIa, IIb and III and must be updated at least every one to two years and submitted to the notified body or – in Switzerland – swissmedic as required. The contents of the PSUR are specified in Annex III of the MDR and in MDCG guidance documents (e.g. MDCG 2022-21).
Authorised representatives have an important role to play in this context: not only are they the communication interface with the authorities, but they must also ensure that manufacturers are informed of any findings. In its report, swissmedic explicitly called on CH-REPs to actively fulfil this responsibility. This responsibility lies equally with EU REPs.
Conclusion: PMS as a Real Duty, not as a Formal Exercise
The swissmedic priority campaign makes it clear that post-marketing surveillance is not an administrative formality. It is an integral part of the safety concept and crucial to confidence in the compliance of medical devices.
Manufacturers – especially those based outside Europe – would be well advised to critically review their PMS systems and ensure complete documentation. This includes a robust PMS plan, a meaningful PSUR, well-documented CAPA processes and close cooperation with their authorised representative.
The next random samples taken by the authorities will come – and they will be more verifiable, more digital and more data-driven. Those who are prepared will have security on their side.
BEO BERLIN is here to help. Whether you need advice on setting up robust PMS reports, a CH representative or a consultant on call, our experts look forward to hearing from you. Your enquiry – send us a mail!
(1 Rating(s), average: 5.00 out of 5)
Loading...
