Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices will apply from May 2021 and May 2022, respectively. Both Regulations say that the European Commission shall set up, maintain and manage a European database on medical devices and in vitro diagnostics called EUDAMED.
The expectations on EUDAMED are high. It shall enable:
- the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and the relevant economic operators as well as about clinical investigations on medical devices;
- the unique identification of devices within the internal market to facilitate their traceability;
- the sponsors of clinical investigations to comply with their legal obligations;
- the manufacturers to comply with their obligations, especially concerning availability of and access to information;
- the competent authorities of the Member States and the Commission to carry out their tasks relating to applicable regulations on a well-informed basis and to enhance the cooperation between them.
In a nutshell, EUDAMED shall increase the quantity and quality of data on medical devices and in vitro diagnostics available to the public, improve transparency and device traceability, enable better health protection via an effective proactive market surveillance, enhance coordination between Member States as well as streamline and facilitate the flow of information among the concerned parties. The database will have a public site and a site with restricted access.
EUDAMED will be composed of different modules, and the first module is expected for December 2020. There have been some delays, but EUDAMED is planned to go live and fully functional in May 2022. Nevertheless, do not underestimate the complexity of EUDAMED and the documents that manufacturers will be asked to provide for the database.
One of these documents is the Summary of Safety and Clinical Performance (SSCP), in which manufacturers should summarise the main safety and performance aspects of the device and the outcomes of the clinical evaluation. The SSCP is required for implantable devices and class III devices. It is composed of two parts: Part A for healthcare professionals and Part B for patients.
The SSCP shall be written in a way that is understandable to the intended user and, if relevant, to the patient. Both parts should be clear and provide information at an appropriate depth to reflect the readers’ different levels of knowledge. It is recommended that the readability of Part B is assessed, for example by a test given to lay persons. The manufacturer may use a method it finds adequate for the readability test to confirm that the SSCP is written in a way that can be understood by lay persons. By the way, these tests are mandatory for medicines since 2005 in Europe.
This might be a challenge for the med-tech industry, for instance because RA/QA professionals are not used to write for the lay audience. In my next webinar, I will give you tips and hints on how to address the requirements set out for writing SSCPs and improving readability. So, stay tuned and do not miss this opportunity!