Our Parent Concern
MEDDEV 2.7.1 Rev 4
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What is MEDDEV 2.7.1 Rev 4?
In 2002, the Medical Devices Experts Group published a report highlighting three concerns/issues relating to conformity assessment. Specific feedback was that:
Issue 1: Manufacturers did not always have clinical data available
Issue 2: NBs did not sufficiently verify the adequacy of the clinical data provided with respect to the characteristics and performances of the device
Issue 3: MDD wording could lead to doubts on interpretation
Attempts were made to address these issues in 2003 with guidance in the form of MEDDEV 2.7/1 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies”. The subsequent amendment to the Medical Device Directive (93/42/EEC) in 2007 (2007/47/EC) added further obligations. MEDDEV 2.7/1 has since undergone a number of iterations, most recently in June 2016 to define a much more robust and systematic approach. The current guidance is MEDDEV 2.7/1 Rev. 4.
Thus, the MEDDEV 2.7.1 Rev.4 is a guidance document that provides guidance for medical device manufacturers and notified bodies who should perform clinical evaluations for medical devices, which fall under 93/42/EEC and 90/385/EEC.
Why is MEDDEV 2.7.1 Rev 4 Important?
In order to sell medical devices in the market in Europe, CE Marking is a legal requirement. CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU).
Clinical evaluation reports are an important step in the path to CE Marking. You must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745, in order to get CE Marking for the medical device.
How does CECD Adhere to MEDDEV 2.7.1 Rev 4?
Medmonts CECD adheres to the following stages of clinical evaluation and references to the given sections and appendices of MEDDEV 2.7.1 Rev 4 document. MEDDEV 2.7/1 Revision 4 brought clarification of what is expected of clinical evaluators. ”Evaluator” or “evaluators” is mentioned 55 times throughout the document. In MEDDEV 2.7.1 Rev 4, specific requirements for the expertise and experience of evaluators are introduced, including a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. For every device that is under evaluation, the manufacturers are required to define requirements for the evaluators and justify the choice of the evaluators through reference to their qualifications and experience. In CECD, we ensure that our team of Clinical Evaluators have adequate experience and experience as indicated by MEDDEV 2.7.1 Rev 4.
Not just these, CECD adheres to all key changes specified by the MEDDEV 2.7.1 Rev 4 guideline and performs the Clinical Evaluation process accordingly.
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