As an essential aspect of MDR compliance, this blog intends to shed some light on Safety and Performance requirements or better: Medical Device Vigilance (MDV) in general.
Naturally, MDV as part of Post Market Surveillance (PMS) is deployed to guard the Safety and improve the Performance of medical devices and are planned, elaborated, and where needed optimized and adjusted. MDV plans should be recorded within the technical documentation prior to CE marking and are executed subsequent to its availability on the market.
Several aspects of this process have been intensified in the new MDR. For instance, User safety & Product performance, the supply chain, the Quality Management System (QMS) are affected significantly and we’ll discuss those in this blog. Most of these issues can be mitigated by performing an audit in which you use to identify GAPs and consequently use to set up a MDR-ready system.
So who should be reading this? Basically, every Economic Operator in the EU who’s involved in Medical Device industry.
Or as defined in the MDR:
‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3)
User safety & Product performance
Implementation of the mandatory MDV is to guard the two integral focuses of any medical device: User Safety and Product Performance. In the fourth pre-amble of the MDR, MDV is stressed as a key element of the regulatory approach and chapter VII is devoted almost entirely to describing the requirements and obligations regarding PMS and MDV.
Over the course of development, an economic operator is supposed to map a medical device’s User Safety and Product Performance and both require accurate monitoring and where applicable adjustment.
The identification and estimation of the significance of incidents and (adverse) events require in depth research, Root Analysis and Periodic safety update report (PSUR). Subsequent to the results of this analysis, recurrent patterns in complains, (adverse) events and incidents have to be precluded. Accordingly, establishment of the Corrective and Preventive action (CAPA) pinpoints the necessary adjustments and mitigating handlings. Consequently, the results of the analysis determine the magnitude of required adjustments for the QMS.
Quality management system
Economic Operators who must comply with the MDR, should be investing in an efficient roadmap leading to an MDR-proof QMS for their product(s), that much is clear.
According to the MDR this means making sure that:
1. Emphasis on clinical data/evidence, PMS will play a much more extensive role in addition to the clinical evaluation process.
2. The roles and responsibilities of the economic operators, the supply chain from manufacturer to distributor (to patient) has been outlined more clearly in the MDR also regarding the handling of feedback from users (vigilance).
3. The chain must be controlled.
The supply chain is the chain from manufacturer to user. The parties involved are defined by the MDR as ‘economic operator’, which include manufacturer, authorised representative, importer and/or distributor, depending on what is necessary.
Depending on the organisation and the location of the manufacturer on or more economic operators are involved/required for the supply chain. E.g. manufacturers located outside the European Union must have an authorised representative in the European Union.
For the distribution of the medical devices, agreements describing the roles and responsibilities must be in place. This becomes more important in case the manufacturer and the distributor do not belong to the same organisation. Quality agreements then become essential, not only for the distribution of the devices but also for the MDV obligations.
Set up of the QMS
A Manufacturer, whose situation is matching with abovementioned concerns, might by now be interested in taking actions to set-up or insure of a MDR compliant QMS system. Manufacturers and Economic Operators must keep in mind that there is not much of time left since MDR will officially be applicable from May 2020. Taking in account Brexit and the limited number of MDR approved Notified Bodies, this limited amount of time becomes less efficient for Manufacturers to:
Set-up an ISO13485;2016 and MDR compliant Quality System in order to get their MD CE Marked
Upgrade their QMS and CE marking of their MD that is already compliant to MDD on the European Market
Ensure that their QMS; Clinical Evaluations, Risk Management, UDI, PMS and MDV are MDR compliant
Since the manufacturer is responsible for MDV, the QMS must cover the vigilance activities from manufacturer to user. In case the distributors are different legal entities a quality management agreement must be in place to take care of the vigilance responsibilities.
Room for improvement
Although pharmaceutical companies are already familiar with Pharmacovigilance where the adverse events of a drug can be recorded and investigated, keeping in mind that a drug cannot “just” be adjusted, improved or changed once it has been made available on the market.
Within the MD industry, the Medical Device Vigilance systems enables the Manufacturer to improve the Safety and Performance of their medical device(s) according to the obtained complaints, adverse events and incidents from its Users.
So, how exactly do you make sure that all is well and you’ve got yourself covered? The answer is: as a manufacturer (also economic operator) you should perform a vigilance system audit to verify that your supply chain does not only supply to your end users but also ensures that events are reported accordingly.
It’s recommended to make use of an (external) auditor who evaluates and reviews your QMS through out the chain and assesses its compliance to the MDR requirements. Additionally, an Auditor assesses the (non) conformities. Hereby the Manufacturer is insured of a compliant Quality System through out the supply chain and is primed and prepared for the (un)expected audits of authorities.
Furthermore, Economic Operators of self-Certified medical devices, Pharmaceutical Manufacturers of Combination Devices, and Manufacturers of Medical Applications as a stand-alone or as Combination MD are the “Groups in Gray Area”. An (external) MDA might be useful for the “Groups in Gray Area” to evaluate and ensure the compliance of their Products. Of note, beside the benefits of an Audit for MD Manufacturers, the MDR obliges the Manufacturers to Audit their Suppliers as well. This aims to warrant accurate monitoring of MD’s integrity until it reaches the User.