A closer look at the safety and performance requirements of the newly introduced Medical Device Regulation. You may agree that its introduction is a stroke of luck for audiologists and clinicians too.
What comes into your mind when you hear the term Medical Device Regulation (MDR)1?
Already now, I assume, this blog is in danger of not to be read by you. But if you can overcome your feelings for just a few minutes, I promise that you will be pleasantly surprised.
After reading my question, I can imagine your expressive faces and see thought bubbles popping up over your heads. In most cases, they say, “What does it have to do with me?”…“boring”….“dry”… “more rules”… “control”… “restricted freedom”… “more work” etc. This is a very common reaction people with a job like mine are faced with in their daily business.
Good that we all know a coin has two sides. Let’s look at the positives coming up with the introduction of the MDR. In that case, the content of your thought bubbles can be replaced with phrases like “high level of protection of health for patient and users”1, “high standards of quality and safety for medical devices”1, “trust”, “fairness”, “transparency”, “scientific integrity” and “traceability”.
In addition to these positives, the two main aims of the MDR are to harmonize “the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods”1 and to ensure “that data generated in clinical investigations are reliable and robust and that the safety of subjects participating in clinical investigation is protected”1. Especially the latter statement reveals that there is now a much stronger focus on clinical investigations of medical devices involving human subjects through the MDR than in the past which will be subject to the audits and inspections a medical device manufacturer has to undergo on a regular basis.
Coupled with this, performance claims will also be paid greater regulatory attention as they are directly linked to clinical investigations. In other words, the MDR requires the manufacturer to carefully think about formulation of their claims and the provision of sufficient level of evidence.
Specifically, the MDR says that the manufacturer has to “specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical data shall be appropriate in view of the characteristics of the device and its intended purpose”1. When talking about safety and performance, nothing other than claims are meant.
This was the impetus behind Phonak’s establishment of a ‘Claims Manager’ position and the standard operating procedure (SOP) “Claim Management” which provides formal guidelines on how to identify, substantiate and administer a claim at Phonak to be compliant with regulatory requirements and to ensure a high quality standard of marketing communication.
This process includes three main building pieces
1. Claims must be truthful (i.e. substantiated), not misleading (i.e. ambiguous wording) and fair (with consumers and competitors).
2. Claims must be categorized into three different types of claims, each requiring different levels of evidence (clinical, technical, neither).²
3. Claims must be stored in a Claims Evidence Database, and include corresponding evidence.
In this context, the Claims Manager functions as the bridge between multiple stakeholders, such as clinical study sites, marketing communication managers, audiologists, product managers, research and development teams, as well as quality and legal departments. Incorporating an advisory role, the Claims Manager ensures adequate transformation of study data (clinical and technical) into claims.
This highly attractive and challenging role requires the ability to wear multiple hats which help understanding the ‘different languages’ of people with various professional backgrounds and support the evolution of claims into the right direction: Phonak’s high audiological reputation and regulatory compliance, at the same time.
Now, why is the MDR a ‘stroke of luck’ from a Claims Manager’s perspective?
The answer is that the MDR clearly provides guidance for what a medical device manufacturer has to fulfill to conform with the relevant safety and performance requirements. The consequence should be a drastic reduction of the number of claims Phonak makes for each product. The driving force behind this is the Clinical Evaluation Report which a medical device manufacturer has to deliver for each product. MDR requires a separate report for every performance level, every model of hearing instrument, every version of fitting software, every accessory and in our case, even every app.
The execution of a clinical evaluation is defined by the MDR as “… a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer” throughout the entire life-cycle of a product.
This means that the significant reduction of number of claims per product forces us think even more about powerful and substantiated claims which are easily remembered by everyone – a stroke of luck for the audiologists, clinicians and their clients, too!
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
2 Hearing Industries Association (2009). Guidelines for Hearing Aid Manufacturers for Substantiation of Performance Claims. Retrieved from http://thehearingblog.com/wp-content/uploads/HIA-Substantiation-Guidelines.pdf, accessed June 14th, 2018.