• Psephos

MDR Clinical Strategy & Evidence Requirements for CE Marking Workshop

This one day workshop was run by SEHTA and Psephos Biomedica on 16 October 2019


Clinical strategy, evidence and evaluation are central to product approval and market access.

Through clinical data a company is able to ensure:

  • that their medical device is able to obtain CE Marking and other regulatory approvals;

  • that the device performs clinically in both a safe and effective manner per the intended use and in the indicated patient population; and

  • that they are able to place it on the market supported by sufficient clinical evidence for user adoption and reimbursement.

It is a requirement of the new EU Medical Device Regulation that a medical device company have a regulatory strategy and of the MDR and MEDDEV 2.7/1 rev 4 that the company have a clinical evaluation strategy.

In order to effectively market their device and generate sales, organisations need to have considered well in advance the clinical elements for market access as failure to do so may put them back months, through not understanding and obtaining appropriate data when initially gathering clinical evidence.

Notified Bodies and regulatory authorities are placing greater emphasis on clinical evidence. Competent Authorities and regulators in other countries are also looking at clinical data and expecting up to date evidence. In addition, purchasers of devices are increasing their requirements for clinical evidence that demonstrates good clinical outcomes and value (evidence-based medicine). The need for clinical evidence and evaluation is a core theme and needs to be captured to satisfy regulators, notified bodies, patients, physicians, procurement, reimbursement agencies (e.g. NICE), etc.

Companies need to be prepared and have solutions in place to address this and their ongoing clinical requirements. Getting your clinical strategy wrong will delay approval and also market access.

What was covered:

  • How to provide an overview of how to Access the Market (CE Marking)

  • Help you to maintain Access to the Market

  • Gain an overview of the new EU Medical Device CE marking Process

  • Understand the key areas of compliance required

  • Understand the technical documentation that should be in place for each device

  • Gain a plan of action for implementation and CE Marking under the new legislation

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