An audiological researcher at Phonak shares 4 learnings from the first clinical study done at Phonak under new medical device regulation.
2021 was a big year in the world of hearing aid manufacturing. It was the year the Medical Device Regulation (MDR) came into full effect.
What is the MDR? The MDR is a new law that replaced the Medical Devices Directive (MDD). It combines a previous set of country specific laws to one European regulation, valid for all EU countries. It applies to all medical devices to be sold in Europe, which includes hearing aids, fitting software, apps and accessories (e.g. chargers, remote controls).
The aim of the MDR is to ensure a high level of protection for users and a smooth functioning of the internal (EU) market. It applies to the design and development, through to manufacturing and marketing of devices.
Few key differences between the new MDR and MDD
- The new regulation is much longer and more detailed than the MDD. For example, the MDR document is 174 pages in length, compared to 60 pages.
- There is also a much stronger focus on clinical investigations involving human subjects through the MDR. This is important at Phonak since our clinical trials are done with real people testing our products.
- Timelines for obtaining approvals have shifted. For example, getting approval for CE* marking now takes up to 6 months (previously up to 1 month).
What does this mean for us at Phonak? To not delay the launch of new products, we must now test products while they are awaiting CE marking, which means involving local regulatory authorities.
I recently put together our first clinical study of a device without CE marking under the new MDR requirement – for our latest hearing aid for unilateral hearing loss. Here are my learnings.
4 learnings from first clinical study under the new MDR
- Planning and submission take many, many months
When we first started working on this clinical trial in March 2021, we expected to submit the clinical trial paperwork within 2 months to Swiss Ethics and Swissmedic, the responsible regulatory authorities in Switzerland where Phonak Headquarters is located.
However, we realized that the approval takes much longer due to the detailed documents that need to be completed, plus the review process. Approval from the authorities is crucial, as we are quite rightly unable to start the study without it.
In fact, the initial planning and submission of the clinical trial took almost 5 months, and the official bodies approved them in a further 2 months. All in all, the process from planning, submission and approval took 7 months, much longer than the original 2 months planned.
- Approval requires input from all parts of the organization
It was clear early on that to meet the requirements; we needed a multidisciplinary team to work on different documents collaboratively. The team was built from colleagues with expertise in statistics, medical device regulations, clinical affairs and data regulations. Also, a study manager, audiology manager, product manager and a project manager were assigned, all working closely together.
- Submission requires a lot of documentation
In total 320 files, including paperwork for initial submission and resubmission were prepared! An overall list of all necessary documents gave us excellent guidance on what was needed for the submission process.
These documents included: safety assurance, biocompatibility statements, a list of the international standard tests carried out on the device, performance verification, a clinical investigation plan and an investigator brochure, which summarizes all the relevant information related to the hearing aid.
- Approval requires a detailed ‘cookbook’ document
The most crucial document that we prepared was the highly detailed and informative clinical investigation plan which covers the technology being tested and who it is designed for, the purpose and protocol of the study and the intended statistical analysis for drawing conclusions about the results.
This was 17 chapters in total, almost 100 pages long, and explained every single aspect of the study. This study ‘cookbook’ is invaluable for the authorities as well as our internal teams, providing guidance and inspiration for the current, as well as future, studies.
Looking back, I am proud to have been a part of the first successful submission of a Phonak device without CE marking. This experience will help us in our planning for future clinical trials and applications should go faster now that we know how to make a successful one.
So, what’s our take home message? Validating new technologies is long and complex, but worth it to provide the most beneficial products possible for you and your clients. With good planning, an effective multi-disciplinary team and clear protocols and guidelines, hearing manufacturers can embrace the new MDR.
*CE (‘Conformité Européene’) serves as a declaration from the manufacturer that their product complies with the essential requirements of the relevant European health, safety and environmental legislation laid out in the different product directives.