This webinar explains the process for Notified Body transfer and Registrar selection for any company that is faced with an urgent need to transfer, because their current Notified Body is unable to review and approve CE Marking applications in a timely manner or if the Notified Body is in the process of losing the status of designated Notified Body.
On Thursday, June 23 the UK voted to exit the European Union (i.e., Britex). MHRA will continue to regulate medical devices sold in the UK and it is unlikely the UK will implement a system that is radically different from the current medical device regulations. However, there are several Notified Bodies that are designated by the UK for issuing CE Certificates to manufacturers of medical devices. The two largest of these are BSI and SGS. Both companies will no longer be British Notified Bodies when the transition out of the EU is complete.
This means that these two Notified Bodies will need to either become Notified Bodies in another EU country or they will no longer be a Notified Body. Even if these two Notified Bodies are able to acquire another existing Notified Body, and/or move their operations to another EU member state, all of the existing certificates will need to be transferred. Certificates will remain valid for a transition period and the new European Medical Device Regulations will require new certificates within the next 7 years anyway. However, if BSI and SGS are not able to re-issue CE Certificates, then customers will be forced to transfer to other Notified Bodies.
I will be gathering information from various Notified Bodies during the next couple of weeks regarding the Notified Body transfer process and providing a summary of my findings. In addition, I will also explain why manufacturers should not get nervous and worry that their certificates are in jeopardy.
The information presented will also explain strategies for avoiding transfer to a new Notified Body and how to avoid some of the pitfalls of the transfer process if you choose to proceed with a transfer.
When is this webinar?
On Thursday, August 4 we will be hosting a live webinar on the Notified Body Transfer and Registrar Selection at 10am EDT.
Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $129. There will be 25-35 slides during the 45-minute presentation and 0-15 minutes of answering questions submitted through the live chat window or via email after the webinar. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Please submit questions to me by email at email@example.com regarding the webinar on Notified Body Transfer and Registrar Selection as soon as possible so that I can get detailed answers for you. During the live webinar you are only be able to submit questions via the chat box. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.
Notified Body Transfers and Registrar Selection Webinar available for $129.00:
Access to a live webinar, native slide deck for this live webinar and a link to download a recording of the live webinar after the live event.
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About Your Instructor
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.