Clinical Evaluation Requirements - Ensure Regulatory Compliance
The clinical evaluation requirements of MDR can no longer be just a report as it was under MEDDEV. Instead a clinical compilation of evidence must be provided within a series of outputs designed to ensure a clear demonstration of efficacy and safety.
The new regulation consolidates two existing legal provisions and replaces both the MDD and the Active Implantable Medical Device Directive (AIMMD 90/385/EEC). It is a fundamental revision of the directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures a high level of safety whilst supporting innovation. It was triggered by the breast implants scandal (as well as other high risk events) where these implants had been approved but had very little safety and clinical evidence associated with them
There will now be several items that have to be covered within the clinical evaluation process under MDR, all inextricably linked to post-market surveillance (also expanded under MDR) and risk management:
- Clinical Development Plan (CDP)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Clinical Investigations
- Summary of safety and clinical performance(SSCP)
- Common Specifications
- Post-market surveillance (PMS) / Product Safety Update Reportactivities (PSUR)
- Post-market Clinical Follow-Up (PMCF).
It’s clear that the area of clinical evaluation, never intended to be lacking under MEDDEV, but with expanded and more prescriptive requirements, now highlights what could be a mountain of work to for many manufacturers as they transition to MDR. Specific focus and attention to detailis needed to ascertain the requirements most relevant to a manufacturer’s own devices as the clinical evaluation and evidence requirements are linked to other facets of the MDR in varying levels of depth – i.e. risk management, GSPR, conformity assessment etc. The transition to meet clinical requirements cannot be planned in isolation and a holistic review of requirements must be conducted with multi-functional groups across a company in Regulatory, Quality, Engineering, R&D, Commercial, Sales & Marketing, Finance, HR and Project Management, as well as Production representatives.
Manufacturers should read and understand the MDR to prepare for the changes ahead, and check with their notified bodies for consistency or agreement in interpretation. A commercial review of a product’s value and forecast is essential as the cost of implementing the new requirements could be more than the product value and be commercially unviable,unless it is a route to other markets or platform for selling other products. A manufacturer must also consider any devices not previously classified as in many cases, these are unlikely to have any technical documentation and this must be prepared retrospectively in its entirety.
For more more detail on the clincial evaluation steps required under MDR 2017/745 as well as a summary of the key areas of focus to ensure regulatory compliance download our new white paper here.
Mi3 provide comprehensive medical device regulatory consulting services – with Mi3 Quality Management Systems certified and audited to ISO 13485: 2016 via the Medical Device Single Audit Programme (MDSAP).
Contact us today to talk to a member of our experienced team on how we can help you prepare for the regulatory requirements of MDR.