Why was the requirement for an SSCP introduced?

The MDR was drafted following a number of high-profile medical device failures which received significant media attention. The subsequent investigations undertaken by EU Member States identified two recurring themes, both of which are indirectly related to transparency. These were considered fundamental weaknesses of the existing European Medical Devices Directive 93/42/EEC (EU MDD) and European Active Implantable Medical Devices Directive (EU AIMDD), which needed to be corrected by new instruments in the EU MDR. One of these themes was focused on the perception within the medical community that insufficient clinical expertise was involved in regulatory decision-making. Associated with this was an acknowledgement that objective criteria and clinical benchmarks upon which to make these decisions were often lacking or poorly defined. The other theme was related to access to information. For example, if the clinical evidence available in the public domain for a given device seemed inadequate, clinical stakeholders may have approached the notified body or competent authority responsible, expecting to get a better understanding of the basis for certification. However, under EU MDD, none of this information could be disclosed without the manufacturer’s consent. Similarly, patients suffering the consequences of a device failure would have struggled to obtain further information if not readily disclosed by the manufacturer.

These challenges related to transparency are due to confidentiality clauses common to all EU Directives and Regulations. Under the EU MDD, notified bodies cannot legally disclose any information provided to them as part of a conformity assessment, including information relating to the evidence for safety, performance and clinical benefit of a device. Although this prohibition is not changed under the EU MDR, there are several new provisions to increase transparency and access to information. The foundation for these instruments is encapsulated in the recitals. With respect to the Summary of Safety and Clinical Performance (SSCP), Recital 43 is particularly relevant:

“(43) Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.”

The SSCP is therefore one means by which the objectives of Recital 43 of the EU MDR are intended to be fulfilled.

This is an excerpt from the latest BSI medical devices white paper: Guidance on MDCG 2019-9: Summary of Safety and Clinical Performance. To find out more about SSCP, the MDR and the MDCG 2019-9 guidance download the full white paper.