Clinical data is the information derived from the use of medical devices that pertains to the devices’ safety and performance. Therefore, clinical data is presented as evidence of these two aspects being fulfilled as well as for conformity assessment purposes. Such data, can be generated following two different paths:
- Collection of primary clinical data via clinical investigation conducted in relation to the device in question;
- Demonstrate safety and performance on the basis of publicly available data such as scientific literature or data on equivalent devices.
With the introduction of the Medical Devices Regulation 2017/745 (MDR) – repealing and replacing Directive (MDD) 93/42/EEC – the regulatory requirements for the collection of clinical data, and its acceptability criteria as clinical evidence will become considerably stricter. Likewise, changes will also be introduced to the ways in which data is assessed and the ways in which it is stored and made available to citizens and stakeholders alike. The rationale behind the MDR’s elevated requirements for satisfactory clinical data is to improve health and safety through increasing transparency and traceability throughout the lifecycle of a medical device.
Changes in clinical data collection
The currently widespread practice of device equivalence as a means of providing clinical evidence of conformity will be restricted by the introduction of new requirements. Claims of equivalence in relation to existing data will be challenged on more grounds as manufacturers will have to prove that their device has the same technical, biological and clinical characteristics as that of the device whose data they are claiming equivalence to.
Clinical evaluation reports (CERs) compiled on the basis of current device equivalence standards, will have to be updated to withstand the scrutiny of Notified Bodies (NBs) under the new standards of proving device equivalence.
Moreover, the MDR will introduce an array of new requirements in relation to primary clinical data collection, i.e. clinical investigations. Under the MDD, class I devices are required to be accompanied by clinical evaluation reports (CERs) while clinical investigations are reserved for higher risk devices. The MDR still requires CERs but the criteria dictating the acceptability of the content will be changed. This is particularly so for implantable and class III devices, for which a user-friendly, “public summary of safety and clinical performance” will have to be compiled by virtue of Article 32 MDR.
Changes in the assessment of clinical data
Similarly, to the elevated standards for the collection of clinical data, the standards pertaining to its assessment will equally be increased. In achieving this, the MDR transforms the role of Notified Bodies into entities mandated with extensive scrutinising and evaluating powers. More specifically, the MDR sets out an expectation for NBs to provide clinical evaluation assessment reports (CEAR), essentially scrutinising the clinical data that comprises the clinical evaluation. Moreover, expert panels will be available to manufactures who can voluntarily reach out to them for preliminary consultations regarding clinical evaluation and investigation strategies, prior to having their clinical data reviewed as part of their device’s conformity assessment.
In terms of post-market clinical follow-up (PMCF) the MDR introduces a more dynamic regime (Annex XIV Part B). NBs will be continuously scrutinising the methodology by which new clinical data will be gathered and reported upon, as opposed to the MDD approach which is closer to a one-off check-list.
Changes in the availability and transparency of clinical data
The MDR will also alter the way in which clinical data is stored and made available. More specifically, under the MDR, Eudamed will be transformed from an information repository solely accessible by the European Commission and national CA for post-market surveillance purposes, to a public database.
Eudamed will also include information on clinical investigations (and the resultant data). In this way, the sharing of clinical data amongst stakeholders and regulators will become more efficient, while the mandatory use of Eudamed by all manufacturers will reinforce the exchange of information. The expected date for Eudamed to start receiving applications is 26/05/2020, but in case of any delay, manufacturers will have up to 6 months to start using the database from the moment it is fully functional.
Any change of a regulatory framework is bound to produce some regulatory burden in the short and medium- term and the MDR is no exception. The introduction of changes and stricter conformity criteria will test all industry stakeholders who will have to be adaptive and pro-active in order to make the transition as seamless as possible. This initial burden is, however, expected to be offset by a regime that finally establishes maximum harmonisation throughout Europe and removes national requirements and peculiarities that also raised regulatory barriers to entry.
For more information on how the new Regulation will impact clinical data, and how you can minimise this impact for your devices, please contact us .