Many European and IMDRF documents refer to ISO 14155 as a ‘conformity’ standard. So it is an important tool to demonstrate compliance with the EU regulatory requirements.
Especially when performing clinical evaluation to demonstrate and provide clinical evidence what is needed and required to support defined medical claim of the medical device under CE marking. Requirement in the EU Medical Device Regulations (MDR).
By doing a GAP analysis and assessment of your technical file (DHF, DMF), it is not always possible to strictly align the applicable MDR wordings in the medical device investigation plan.
The requirements in the ISO 14155 provide in-depth guidance on the methodology to conduct clinical investigations. Although these requirements do not refer to specific national nor regional strict regulatory requirements, ISO 14155 is an excellent useful document ‘tool’ as guidance for clinical investigation and clinical evaluation with medical devices.
Other relevant requirements or guidance’s are:
- Declaration of Helsinki
- ICH Guidance
- Good Clinical Practice (GCP) for clinical trials
The MDR provide also a more in-depth focusing on the quality assurance aspects of the investigational medical device itself. The MDR aligns important elements of the ISO 13485, and the FDA QSR, such as
- The medical device is ready for human use, including any updates of the investigation brochure contents and when design changes may occur during a clinical investigation;
- Sufficient information is provided to assure safe use of the investigational devices, with greater emphasis on user training;
- Device malfunction reporting is accurate; and
- Safe disposition of unused devices.
The ISO 14155 standard states its scope includes both pre- and post-market clinical investigations, while explaining that if the sponsor wishes to deviate from its requirements, a justification must be given.
This raises several questions including; ‘ What elements of the ISO 14155 standard are voluntary and when?’; ‘What type of clinical investigations are we talking about?’
To answer these questions it is important to define:
(A) the different phases of clinical investigations:
(B) the design of the investigation plan:
(C ) examples of earlier studies in each phase
(D) motivation of the statistical considerations in the investigational plan;
(E) Risk Management considerations (i.e. ISO 14971)
(F) Ethical considerations.
As professional EU Authorized Representative service provider we’re looking forward to support you in your efforts to be in compliance with the EU regulatory requirements (MDR)! Please contact us for support and or for required clinical expertise.