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  • First, recognize that there four types of procedure pack. One type meets Art 22(1), while the other three are in Art. 22(4). The first type does not a CE Mark or NB involvement. The other three types are devices in their own right. They follow the Art. 52 conformity assessment and the natural or legal person is a manufacturer. In all four cases the ...

  • There's also a nice compilation of references on the FDA web page "Wireless Medical Devices". https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices ​ ------------------------------ Anne LeBlanc Manager, Regulatory Affairs United States ------------------------------

  • The best approach is probably to write a procedure for your company, and then follow it. The most relevant US information to review is compiled on the FDA web page "For Industry: Using Social Media". https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/industry-using-social-media I haven't seen anything that specific for EU or CA, ...

  • Hello Anon, At this point in time, I would highly recommend you disconnect any UDI requirements for the product and UDI information contained in EUDAMED. First, UDI requirements for the product: regardless if EUDAMED is working or not, the actual physical product must have the UDI on the product labelling as of the dates defined in Article 123 for ...

  • Hello Anon, There are many aspects which need to be addressed by your question which can not probably be answered succinctly in a single forum post.  Your questions about new labelling or new products manufactured in the new site depends much on type of product, what the labelling constitutes, shelf-life of the product, what you have in inventory, ...

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Volunteer Appreciation 2020

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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