To satisfy the requirements of the European Union Medical Device Regulation, every medical device sold in EU – irrespective of its classification – must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical Documentation.
Impact of MEDDEV 2.7/1 Rev 4
MEDDEV 2.7/1 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” provides a systematic and robust approach for CER processes. Although technically MEDDEV 2.7/1 is a guideline and not a regulation, Notified Bodies expect that medical device manufacturers will comply with MEDDEV.
In June 2016, Rev 4 replaced Rev 3, and the changes between the two revisions were substantial. Rev 4 is more prescriptive and requires manufacturers to provide greater quantity and quality of information for clinical evaluations. Further, the guideline now places much higher scrutiny on content of clinical evaluation reports, postmarket planning, and supporting clinical evidence of any medical device. Organizations need to be aware that this applies to all medical devices, regardless of class or how long they have been safely sold on the market.
Impact of EU MDR on Your Medical Device CER
Under the new EU MDR the content required in the CER has changed. Additional safety and clinical evidence may be required for certain device types and classes of devices. This applies to devices already on the market as well as new products. For example, Class III and many implantable devices will be required to have clinical investigations completed, including postmarket clinical follow-up.
How Can Oriel STAT A MATRIX Help?
MDR Impact Assessment
Oriel STAT A MATRIX can conduct an impact assessment of the requirements of the MDR as they relate to your products. This includes a review of the device’s classifications and the associated regulatory and quality system requirements. This information will help you understand the documentation impact of the EU MDR on your CERs, so that you can determine the level of effort required to ensure they are compliant.
EU CER Assessment
Oriel STAT A MATRIX can conduct an assessment of your company’s device or family of devices and the requirements of MEDDEV 2.7/1 Rev 4, develop a report that will define and prioritize the risks facing your company, and provide recommendations on when and how to mitigate the risks. It is important to note that your product classification may have changed under the new EU MDR, which can have a substantial impact on the level of effort needed to become compliant.
Medical Device Clinical Evaluation Plan Strategy
Oriel STAT A MATRIX can help you create a Clinical Evaluation Plan (CEP) strategy outlining key elements to consider for the CER in order to meet the requirements of MEDDEV 2.7/1 Rev 4 and the EU MDR. This includes:
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Evaluation of options for equivalence
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Evaluation of options for state of the art
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Suggestions for potential sources of clinical data and when a clinical investigation may be needed
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Suggestions for sources and types of postmarket surveillance data
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Suggestions for sources of nonclinical data
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General guidance
Clinical Evaluation Plan
Oriel STAT A MATRIX can develop a CEP for the CER to outline the requirements for equivalency, state of the art, qualified evaluators, data sources to be used (e.g., literature search or clinical investigation), and postmarket surveillance as recommended in MEDDEV 2.7/1 Rev 4 and the EU MDR.
Clinical Evaluation Report
Oriel STAT A MATRIX can prepare a CER to establish conformity to the essential requirements, a positive risk/benefit profile, postmarket requirements, and frequency of updates.
Clinical Literature Review Safety and Performance
Oriel STAT A MATRIX can conduct a safety and performance clinical literature review (using multiple databases) that includes a literature review protocol; identifies, appraises, and analyzes the literature to substantiate the clinical need, safety, and performance; and concludes with a report summarizing the findings.
Why Choose Oriel STAT A MATRIX
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We have extensive experience developing EU CERs, Technical Files, and quality systems.
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We have a global team – our consultants are based in in 33 states and more than 20 countries, and our team has assisted customers in more than 75 countries.
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We offer project management and set deliverables with defined timelines – we partner with you to keep projects on track and deliver in accordance with a predefined schedule.
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We are experts in performance excellence and regulatory compliance – we merge our expertise in regulatory compliance with performance excellence methodologies to ensure efficiency in our engagements.