Clinical evaluation under EU MDR

There has been significant evolution in the European regulatory landscape over the past 10–15 years, particularly with respect to requirements for clinical evaluation. These changes have been driven in part by a series of medical device failures, which fuelled a perception, particularly amongst regulators and clinicians, that clinical evidence for medical devices was not receiving sufficient scrutiny in Europe.

One of the early markers of this shift came with the publication of Directive 2007/47/EC in September 2007, which amended the European Active Implantable Medical Devices Directive (90/385/EEC, EU AIMDD) and the European Medical Devices Directive (93/42/EEC, EU MDD). Although the scope of Directive 2007/47/EC was not limited to clinical evaluation, many of the amendments had a direct impact on clinical evaluation and postmarket data collection. Amongst these were:

• A new definition of ‘clinical data’ was added to Article 1 of both Directives, including a specification of acceptable sources of clinical evidence.
• The requirement for demonstration of conformity with the Essential Requirements (ERs) to include a clinical evaluation was moved from the ‘design and construction’ specific section of Annex 1/I to the ‘general’ section. The implication of this change was that clinical evaluation was an explicit requirement for all devices, regardless of design or intended purpose.
• Substantial amendments were made to Annex 7/X (clinical evaluation), including:
  • clinical investigation required by default for all Class III and implantable devices; any decision not to undertake a clinical investigation for these devices must be duly justified
  • clinical evaluation must be documented as part of the technical documentation
  • the clinical evaluation and its documentation must be actively updated with data obtained from postmarket surveillance
  • if postmarket clinical follow-up is not deemed necessary, this must be duly justified and documented.

Following the publication of Directive 2007/47/EC, there came a succession of new and revised guidance documents and legislation. The intent of many of these changes was to improve the quality of medical device clinical evaluations and the scrutiny to which they were subject. Table 1 is intended to be illustrative rather than exhaustive.

Cumulatively these changes have shaped and reinforced the current practices, particularly with respect to parameters which affect the validity of the process and conclusions drawn:

• scope and clinical evaluation planning
• data collection methods
• data appraisal and analysis
• data mapping, benefit-risk evaluation and conclusions on ‘sufficient clinical evidence’

This blog post is an excerpt from our latest whitepaper: Clinical evaluation under EU MDR. Please download the full whitepaper to find out more information.