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The new Medical Device Regulation 2017-745: Safety by design and by vigilance
12-12-2018

#The new Medical Device Regulation 2017-745: Safety by design and by vigilance

As an essential aspect of compliance to the new Medical Device Regulation 2017-745, this blog intends to shed some light on safety and performance requirements for medical devices and the way to monitor this, or better: vigilance in general. Of course, the scope of this blog also encompasses the In Vitro Diagnostic Regulation 2017-746, because vigilance is applicable to both.

Naturally, vigilance as part post-production activities, as well as post-market surveillance (PMS) are deployed to guard the safety and improve the performance of medical devices. Procedures for vigilance and PMS should be set up carefully, planned for, elaborated and where needed optimized and adjusted. Even so, PMS plans should be recorded within the technical documentation prior to CE marking and should be executed subsequent to its availability to the market. Several aspects of these processes have been intensified in the new MDR as compared to the Medical Device Directive (MDD). For instance, safety & performance, the supply chain and the Quality Management System (QMS) are affected significantly and we’ll discuss those in this blog. Potential issues can be identified by performing an audit on vigilance and PMS plans, so that identified gaps can be addressed appropriately and result in an MDR-ready system.

So who should be reading this? Basically, every economic operator in the EU who’s involved in the medical device industry and especially the manufacturer.

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)

Note: article 22(1) and 22(3) deal with the person who combines devices bearing a CE mark into a system or a procedure pack.


Product Safety & Performance

Implementation of the mandatory vigilance is to guard the two integral focuses of any economic operator involved with medical devices: safety and product performance. In the fourth pre-amble of the MDR, vigilance 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 vigilance.

Over the course of development, the manufacturer is supposed to map a medical device’s safety and performance and both require accurate monitoring and where applicable adjustment.

The identification and estimation of the significance of incidents in the commercial lifecycle of a medical device and (adverse) events in the developmental (clinical) phase require in-depth research, root cause analysis and Periodic Safety Update report (PSUR). Subsequent to the results of this analysis, recurrent patterns in complaints, (adverse) events and incidents have to be precluded. Accordingly, the 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 design of the medical device and the QMS if needed.


Quality management system

In order to comply with the MDR, economic operators should invest 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 and vigilance 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 the patient) have been outlined also regarding the handling of feedback from users, patients, healthcare providers, and other stakeholders, e.g. vigilance).
  3. The chain must be controlled.

 


Supply chain

The supply chain is the path a medical device travels from the manufacturer to the final destination of use. The parties involved are defined by the MDR as economic operators, which include manufacturer, authorised representative, importer and/or distributor, depending on what is necessary.

Depending on the organisation and the location of the manufacturer one, or more economic operators are involved/required for the supply chain. E.g., manufacturers located outside the European Union must have an authorised representative residing in the European Union.

For the supply chain 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 vigilance 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 an MDR compliant QMS system. Manufacturers and other economic operators must keep in mind that there is not much of time left since MDR will officially be applicable from May 2020. Taking into account Brexit and the limited number of Notified Bodies that will be approved for the MDR, this limited amount of time becomes a constraint for manufacturers to:

  • Set-up an ISO13485:2016 and MDR compliant Quality System in order to get the medical device CE marked
  • Upgrade the QMS and CE marking of devices that are already compliant to the MDD on the European Market
  • Ensure that specific elements are also MDR compliant, e.g. Clinical Evaluation, Risk Management and Unique Device Identification (UDI)

Since the manufacturer is responsible for vigilance, the QMS must cover the feedback activities as well as trending and vigilance, from manufacturer to user. In case the distributors/importer are different legal entities, a quality agreement must be in place to take care of the vigilance responsibilities.


Room for improvement: pharmaceutical companies

It is a trend that pharmaceutical companies are more and more directly involved with medical devices, not only as a simple means to administer medicinal products. For example, they are involved in the development of novel combination products, where a drug is combined into a single unit with a device; also software as a medical device, better known as apps, is a new field where they are active in. Pharmaceutical companies are already familiar with pharmacovigilance, where the adverse events of a drug can be recorded and investigated. Vigilance for medical devices is at first sight similar, but it is not the same as pharmacovigilance. Therefore, pharmaceutical companies also handling medical devices must bring their systems in line with the MDD and/or the MDR to ensure that the requirements are met; to help them meet this goal, several Medical Device Guidance Documents (MEDDEVs) are available.

Within the medical device industry, the vigilance system gives input to the manufacturer to improve the safety and performance of their medical device (-s). Also, other means can be used for this, e.g. post-production information, feedback, and complaints from users, patients, healthcare providers, and other stakeholders

From a business efficiency perspective, it’s interesting for companies to investigate how to integrate their Pharmacovigilance and (material- or medical device) vigilance systems. Instead of having two separate systems with their own upkeep, a well-combined system can be both compliant and cost-effective.


Checks and balances: auditing

So, how exactly do you make sure that all is well and you’ve got yourself covered? The answer is: as a manufacturer (or any economic operator), you should perform a system audit to verify that your supply chain does not only supply to your end users but also ensures that events are reported accordingly, vigilance and that proper feedback from the market is obtained, post-market surveillance.

It’s recommended to make use of an (external) medical device vigilance auditor who evaluates and reviews your QMS throughout the chain and assesses its compliance to the MDR requirements. Additionally, an MDVA assesses also any non-conformities. Hereby the manufacturer is insured of a compliant Quality System throughout the supply chain and is primed and prepared for the audits of authorities and/or Notified Bodies.

Manufacturers of certain categories of medical devices might benefit specifically from such an audit because they are so-called ‘out of the ordinary’. Such devices are:

  • Self-certified medical devices; the classification criteria of medical devices are stricter whereby numerous Class I (self-certified) devices would be classified as Class IIa/b according to the MDR
  • Drug-device combination products; are classified as Class III whereby the safety and compatibility of the device, medicinal product and the combination of these two must be substantiated
  • Software as a medical device; is classified as Class IIa/b contingent to its (remote) options, configurational abilities, and risks with respect to the critical parameters

Naturally, for you as a manufacturer of Class II and/or higher Classes of medical devices, an audit will contribute to ensuring that the setup and maintenance of vigilance and post-market surveillance plan/method are performed appropriately. Of note, besides the benefits of an audit for medical device manufacturers, the MDR obliges the manufacturers to audit their critical subcontractors and suppliers as well. This aims to warrant accurate monitoring of the medical device’s integrity until it reaches the user/patient.

If you’d like to do your own pre-audit, you might want to start out with a free checklist for Medical Device Vigilance: request here.


In conclusion

The new MDR has been around for some time now and one of its focal points is the safety and performance of medical devices. To achieve this a manufacturer of medical devices, and even all economic operators, are legally obliged to set-up, implement and maintain an effective system for both vigilance and post-market surveillance. To check if the system is working properly, it should be subject of an internal audit. In this way, any third-party inspection will have a fully compliant outcome and, most important, the safety and performance are warranted for the patients.

Often we encounter situations within the medical device supply chain that an economic operator, manufacturer or not, is assuming its vigilance and PMS system to be compliant. Nevetherless, by asking right questions the contrary is proven. Thus, how do YOU ensure that the vigilance and post-market surveillance of YOUR product are fully compliant?

Blog by: Nadia Vazirpanah & Marc Klinkhamer


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