QMS and pre-market clinical investigations

QMS and pre-market clinical investigations

It can be anticipated that most manufacturers will demonstrate compliance with the MDR by means of conformity assessment based on a QMS and assessment of technical documentation, as specified in MDR Annex IX. Section 2.2(c) requires that the documentation to be submitted for the assessment of the QMS includes an adequate description of: the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records arising from those procedures and techniques. Eight different elements that the procedures and techniques need to address are specified and, in brief, are:

• strategy for regulatory compliance
• identification of applicable GSPRs
• risk management
• clinical evaluation
• solutions for fulfilling the applicable specific requirements regarding design and construction
• solutions for fulfilling the applicable specific requirements regarding the information to be supplied
• with the device
• device identification procedures and
• management of design or QMS changes

A pre-market clinical investigation is part of the design and development process because it is a design validation activity if it is intended to demonstrate that the device complies with regulatory requirements. Thus, the clinical investigation and its documentation should be managed within the company’s QMS and be addressed during design and development planning, design and development reviews and design validation.

The SOPs that can be helpful in conducting a clinical investigation are discussed later in this paper in the section, ‘Clinical investigation SOPs’

QMS and PMCF investigations

The results of PMCF investigations will need to be documented in the PMCF evaluation report. They will also need to be considered in updating the CER, risk management, PMS report, periodic safety update report, and for implantable devices and class III devices, the summary of safety and clinical performance. The results of the PMCF investigation may also be linked to the need for corrective action or preventive action, or in some cases, to validate a design change made in the post-market period.

For these reasons, manufacturers are encouraged to develop QMS procedures that will address these requirements and linkages to help ensure compliance with these interconnected regulatory requirements.

This blog post is an excerpt from our latest whitepaper: Medical device clinical investigations — What’s new under the MDR? Please download the full whitepaper to find out more information.