New European Regulations: Increased requirements for Clinical Evidence and Data Privacy

Sound Connection | Issue 30 | June 2018

On 25th May 2018 the data protection world changed for European citizens with the introduction of the European Union General Data Protection Regulation (GDPR). As a company Cochlear has always taken data protection seriously. Before the GDPR, Cochlear has consistently ensured that our data handling processes comply with the required standards.

In Clinical and Regulatory Affairs, the new GDPR regulation comes at a time when Cochlear, along with other medical device manufacturers, are in transition for the new European Union Medical Device Regulation (MDR), which will become mandatory in May 2020. Several high-profile incidents such as the PIP breast implant scandal and hip replacement failures triggered the need for reform of the regulations to improve standards and safety for patients. Current medical device regulations date back to the 1990s and haven’t kept pace with developments in science and technology. They also needed updating to support innovation and fair trade throughout the European Union. Even since the new MDR was published in May 2017, the regulatory landscape has changed significantly. Five years ago there were approximately 80 Notified Bodies (the organisations that assess whether manufacturers conform to the regulations and can CE-mark their devices for EU market access) and today they are under 60. There has been increased scrutiny and auditing of Notified Bodies by the regulatory authorities and many simply could not comply or did not want to undertake the increased requirements and closed down.

The effect we see across our organisation and in our daily clinical and regulatory work is the increasing demand for paperwork to support CE-marking of our products. This also includes increased demands for Clinical Evidence to support the safety and performance of our devices.

As European citizens we all benefit from the confidence that medical devices available on the European Union market comply with essential standards and are safe and effective. Under the new MDR the proof of safety and performance is not only required at the time of applying for CE-mark. Manufacturers, especially those of high risk devices such as cochlear implants, are now required to continue monitoring their devices in the market for the lifetime of the products. This is called Post Market Surveillance (PMS). Manufacturers must collect real-life usage data about their devices and provide respective annual reports to their regulators. These reports need to demonstrate that the product continues to perform well and still provides the expected benefit to patients, based on Post Market Clinical Follow-up (PMCF) data collected.

The good news is that Cochlear has always applied a high level of integrity to data protection in all its activities and is, therefore, well-aligned with GDPR requirements. Cochlear adheres to the principles mandated by Good Clinical Practice (GCP), a framework that applies to all clinical studies. GCP requires, for example, that each subject has given explicit Patient Informed Consent (PIC). With PIC the study subject receives a detailed explanation on the conduct of the study, including clear information about the handling and usage of personal data collected.

Since 2011 Cochlear is executing the Implanted Recipient Observational Study (IROS). This study has the objective to collect longitudinal Quality of Life improvement data for the users of our implantable hearing solutions. It became clear that this approach was equally suited to fulfilling PMCF requirements and we therefore continue to use IROS to collect the mandated PMCF data for several of our Acoustic and Cochlear Implant products. More recently we have also adopted the quicker and leaner approach of using clinical questionnaires such as Speech, Spatial and Qualities of Hearing Scores (SSQ12) in marketing type surveys to collect PMCF data.

It is exciting times for Cochlear, especially in Clinical and Regulatory Affairs in responding to the requirements of the new EU Regulations.