RQMIS has authored numerous Technical Files meeting the requirements of the Medical Device Regulation (MDR). A critical part of the Technical File is the Clinical Evaluation Report. We have successfully created CERs per MEDEV Guidance 2.7/1 Rev 4.
RQMIS understands that ~85% of the MDR requirements are covered in the MDD. However, even where the requirements are consistent, the MDR is more prescriptive in what evidence is expected to demonstrate compliance. For example, are residual risks identified in your product risk profile represented in product labeling?
RQMIS provides expert guidance that will ensure your products comply with the MDR and the MEDEV guidance on CERs. RQMIS consultants and medical/technical writers can create or edit your TFs and CERs to assure CE marking success. Our Regulatory/Quality Consultants can establish, update, and implement quality system processes that will assure you apply these new requirements in a consistent and effective manner. RQMIS can also provide annual updates to these files.
A new MDR has replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). All submissions in the EU must conform to the new MDR on 26 May 2020.
What This Means
The new MDR changes the market access landscape for all member countries of the European Union, and it aims to ensure a higher level of protection for patients and users. Some key changes associated with the MDR include:
RQMIS can evaluate your current compliance to the MDR and determine any impacts to your Quality Management System (QMS) and product lines. In addition, RQMIS provides:
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