Dr Gerhard Bauer-Lewerenz, Bauer-Lewerenz Consulting, Bad Homburg, Germany
Since the 1990s, Medical Devices (classical Medical Devices, active Medical Devices and IVDs) have been regulated under the three EU Directives (90/385/EWG/90, 93/42/EWG and 98/79/EG). Triggered by different implementations in the Member States and some incidents with Medical Devices, the new Regulation 2017/745/EU (Medical Device Regulation, MDR) was published. It contains a number of tightenings (e. g. UDI, market surveillance, new classification rules, etc.) and originally should have come into operation on 26 May 2020 after a three-year transition period. Once it has come into force, it will be directly binding for all Member States. There are transitional periods for Medical Devices which were placed on the market under the „old“ Medical Devices Directives.
Due to the corona pandemic, however, the EU has decided to postpone the deadline for one year to 26 May 2021. What does this mean for the concerned companies? Those who have already done all their “homework” can check everything again in a calmer manner. Those who were “just about to do it” will be given time to complete it. The notification of the Notified Bodies was behind schedule, there were “too few Notified Bodies for MDR”. This can now be caught up.
This webinar addresses people from the Medical Device Industry or those involved with Combination Products who are affected by the changes in the Medical Device Regulation.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
This webinar informs about the chances the industry (and Notified Bodies) gets due to the postponement of the Medical Device Regulation. What are the main topics of the MDR? How can the additional time be used?
- Do a complete check
- Update the Technical Documentation
- Bring the risk analysis up to date (especially regarding missing or incomplete literature/preparing for the new ISO 14971)
- More Notified Bodies will get the necessary notification for the MDR; this will also give companies the necessary security
- Update Post-Market Surveillance (collection/evaluation of data)
- Finalise UDI issues
- Simplify forms and complete literature data
- Prepare for the next audits in a calmer manner