Wednesday 16th October 2019
Hill Dickinson, Broadgate Tower, 20 Primrose Street, London EC2A 2EW, 10:30 – 16:00
SEHTA members fee – £250 + VAT per delegate
SEHTA non-members fee – £300 + VAT per delegate
Why attend
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 & 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.
Please note this is for Medical Device firms only – not Pharma or IVD
This one-day workshop will give you:
- An overview of the new EU Medical Device CE Marking Process
- Help you to maintain Access to the Market
- 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
Target Market: C suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall clinical requirements for their medical devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful.
To view an agenda for this event, click here
To register for this event, click here