The new EU MDR has various revisions of the regulview citemed’s literature review processatory aspects covered by the Medical Device Directive (MDD). Therefore, it has launched requirements for those who are seeking CE-mark approval and the professional Body reviewers Authority. Since its publication in 2017, the medical device sector has established the depth of the latest requirements and their impact on the devices. Clinical evaluation is one of the heated topics, and companies have tried to meet the requirements to get the approval of the medical products.
Although it may sound self-explanatory, being proactive seems to be the most critical point in MDR compliance. As such, some companies could wait for a delay hoping that the EU will see their inability to align with the new regulation requirements. Moreover, there is a limited number of professional Bodies with a limited scope of designation. Therefore, because of the workload, the evaluation process may take an extended period. Being proacting will help you strategize your pathway based on the applicability and availability of the professional Body you want to work with.
Understand Applicable Requirements
In the clinical evaluation asper MDR, the first thing is to understand is that it is not just a report. It is the final output of the ongoing evaluation process, a compilation of the clinical evidence that shows conformity to the applicable GSPRs (General Safety and Performance Requirements). Furthermore, generic parts should be covered in the clinical evaluation process, including the development plan, evaluation plan, clinical investigation, and common specifications. By understanding the requirements, you stand a chance of getting your approval.
Be Systematic and Structured
A clinical evaluation has to be well-structured and methodologically sound to facilitate conformity claims. It should be systematic where data can be accessed and summarized through a well-built search combination. Moreover, it should demonstrate how the scientific data conforms with the risk management, device literature, post-market surveillance, and clinical follow-up. Again, the MDR approach will enable you to prepare auditor-friendly documentation.
A clinical evaluation aims to demonstrate that if the devices and products are used under the conditions and purposes intended, it does not pose a danger at all or that is no more than maximum acceptable. The devices and products need to be consistent with a high level of protection for the persons’ health and safety. Besides, ensure that your evaluation process is continuously interactive between various components such as risk documentation, PMCF activities, clinical product literature.