Major investments
The compliance of medical devices with the new regulation 2017/745 is quite complex. For most companies, this would cost more than 5% of their annual income, and more precisely, between 6 and 10%. There are multiple reasons for this cost, the main ones being:
- The time required to understand the regulations
- The time to gather clinical data
- Post-marketing surveillance
It is quite difficult for companies to define a compliance person: they usually recruit 1 to 5 people.
It is important to have clear and defined roles at each stage of the project in order to move forward effectively. Indeed, on average, compliance takes teams at least 5 hours per week. To this must be added the time needed to train new employees. Adapting to the company is a process that can be rather long but is necessary to ensure that the teams are properly integrated, understand the issues and achieve product compliance.
It is therefore not enough to have a product that complies with the regulations at the time of marketing. For medical devices, there is a need for continuous market surveillance through indicators such as user surveys, technical and clinical monitoring, and surveillance of competing devices, to ensure that the device is still safe to use and effective. Collecting this analytical data can be quite tedious, it is a process that lasts over time, even if the product is no longer sold.
Given the magnitude of the task of compliance, using the services of a specialist consultant can be a real opportunity for the companies concerned. Product positioning, assistance in compiling technical dossiers or checking labels are key points of the medical device regulations that your service provider can do. Having a specialist company on your side can save you valuable time.
Furthermore, coaching is considered a key to the success of the compliance process as a consultant is more likely to keep up to date with changes. He often has a much more precise and evolving understanding of the issues and details expected by the regulations and the authorities.
Regulation 2017/745: a challenge
Although new guidance documents are being published to assist in the understanding and interpretation of the regulation, these new obligations require a significant investment of time to get to grips with. The EU Medical Device Regulation contains a large number of references, very specific annexes as well as important revisions that have changed the medical device landscape. Find out more about these changes in this article.
The first step towards compliant products is to find out the class to which the medical device belongs. Depending on the class of the medical device, the obligations, requirements and documents to be provided for the technical dossier may vary. As a result, companies need to anticipate the cost of bringing their products into compliance. Regulation is a mandatory step to continue selling products in Europe. For both small and large companies this represents a considerable cost.
The new regulation puts much more emphasis on the post-marketing phase of devices and the whole life cycle of the product. It is therefore crucial to collect a large amount of data once the device is on the market: it is necessary to ensure its safety and proper functioning over time.
Wish to know more about medical devices?
For more information, do not hesitate to contact Raïssa Abdel Kader or one of our experts!
