Hellow guys, Welcome to my website, and you are watching What means "Placing on the market"? (CE mark Medical Device). and this vIdeo is uploaded by Easy Medical Device at 2018-11-06T08:04:19-08:00. We are pramote this video only for entertainment and educational perpose only. So, I hop you like our website.
| Name | What means "Placing on the market"? (CE mark Medical Device) |
| Video Uploader | Video From Easy Medical Device |
| Upload Date | This Video Uploaded At 06-11-2018 16:04:19 |
| Video Discription | What does it mean to place a product on the market for a Medical Device? [Download Powerpoint Slides - Link below] I try to answer this question as it's not easy to understand the difference when a product is still under the manufacturing control and the product is under the distributor control. This is a critical question for the Medical Device Industry. I use the Medical Device Regulation EU MDR 2017/745 and the blue guide as a reference to provide you the answer to it. There are 3 definitions that are important for a better understanding: - Placing on the market - Making available on the market - Putting into service I show you what is the connection between those 3 definitions. Maybe you ask yourself why is this so important. On the new MDR 2017/745 on Article 120 paragraph 4, there is a sentence saying: "Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025." So for your business survival, this definition is key. If you don't place your product on the market before May 26th, 2020, then they can be lost and the only choice you'll have will be to scrap them. Let me know in the comment if this is really helping you. ---------------------------------------------------------------------------------- Links from the Video - Blog Post: https://easymedicaldevice.com/mdr-transition - EU MDR 2017/745 & Blue Guide (EUROPE): https://easymedicaldevice.com/resource-medical-device-regulation/ - Presentation slides: https://mailchi.mp/f29ec4a61e77/placing-on-the-market ---------------------------------------------------------------------------------- Social Media to follow - Linkedin: https://easymedicaldevice.com/linkedin - Twitter (Monir): https://twitter.com/elazzouzim - Twitter (Easy Medical Device): https://easymedicaldevice.com/twitter - Pinterest: https://easymedicaldevice.com/pinterest - Instagram: https://www.instagram.com/easymedicaldevice - Youtube channel: https://easymedicaldevice.com/youtube ---------------------------------------------------------------------------------- #medtech #medicaldevice #compliance |
| Category | Education |
| Tags | medical device | medtech | medical devices | eu mdr | mdr 2017/745 | 2017/745 | medical device regulation | dispositif médical | ce mark | ce marking | medical device industry | medical devices documentary | medical devices directive | regulatory affairs | medical device approval | medical device certification | medical device regulations | iso 13485 | quality management | medical devices regulations | ce marking process | quality management in healthcare | ce marking guide | eu mdr webinar |
