Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by notified bodies and competent authorities in Europe. That scrutiny - and the burdens placed on medical device manufacturers - leaves some companies at risk of losing their CE certifications following routine notified body re-certification audits.
In this training, we will examine the clinical data and literature review requirements found in MEDDEV 2.7/1 revision 4 as well as the changing regulatory environment as it relates to these requirements.
Objectives of the Presentation
- What is MEDDEV 2.7.1 Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
- What are some of the most significant changes?
- What exactly are the implications of all these changes for device manufacturers?
- How does this affect your CERs?
- How does it align with the changes to the new EU MDR?
- How often you must update your CERs now and what qualifications the evaluators must have?
- How should you prepare for the increased notified body scrutiny?
- How do you perform a clinical literature review to meet the new expectations?
- How long is the transition period going to be?
- Avoid frequent pitfalls of clinical regulatory submissions
- How to ensure continuing compliance throughout device lifecycle
Why Should you Attend
Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.
Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully. If you have existing CERs, you need to develop an action plan to identify and address the gaps. If you will be CE marking a new device, you must ensure you have sufficient clinical data to show compliance with the essential requirements for safety and performance.
- Clinical data requirements in the MDR and MEDDEV 2.7/1 revision 4
- How to determine whether a device is equivalent to your own
- Prepare a clinical evaluation in accordance with MEDDEV 2.7.1 and GHTF guidance documents
- Requirements on searching for literature and whether your clinical literature reviews will be accepted by your notified body
- Collating and appraising the data
- Documenting your evaluation
- Implement risk evaluation pre/post review
- Updating your CERs and the importance of PMS data
- Maintain and update clinical evaluation documentation throughout post-market product lifecycle
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer's instructions for use.
With the release of MEDDEV 2.7.1 Rev 4 June 2016 on clinical evaluations in Europe, the main challenges for device companies in developing CER is to ensure compliance to new requirements and making justification that the available data is sufficient to support the performance and safety of a device.
CEO & Principal Consultant ,
Michor Consulting and Trade Services GmbH
Salma Michor - PhD, MSc, MBA, CMgr, RAC - is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH.
She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission.
She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
Who will Benefit
- Medical Device Presidents and CEOs
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
- All end-users from appropriate departments who desire or require a better understanding or a refresh knowing that every medical device sold in Europe must be supported with a Clinical Evaluation Report in its technical file
- Clinical Affairs