Son of Paperman
Starting to get Involved
Our company designs, manufactures and sells class 1 to 3 medical devices (dental implants, abutments and tools to places them).
Under the current MDD our class 1 devices do not require notified body authorisation for CE-marking. That will change on May 26, 2020 when most likely all those class 1 products must be submitted to the notified body in order to be CE-marked under the MDR.
1) Can we continue to produce and sell our MDD CE-marked class 1 products under our current MDD CE-certificate until it expires on 1 April 2023, or can we only sell products manufactured before May 26, 2020, and must we therefore stock up before May 26 2020 to bridge the time until those class 1 products are CE-marked according to the MDR?
2) If we completely finish the development of our new class 1 products, currently still in the R&D-stage, before 26 May 2020, can we still register them according to the MDD, and not needing notified body authorisation?
Thank very much in advance for your help.
Under the current MDD our class 1 devices do not require notified body authorisation for CE-marking. That will change on May 26, 2020 when most likely all those class 1 products must be submitted to the notified body in order to be CE-marked under the MDR.
1) Can we continue to produce and sell our MDD CE-marked class 1 products under our current MDD CE-certificate until it expires on 1 April 2023, or can we only sell products manufactured before May 26, 2020, and must we therefore stock up before May 26 2020 to bridge the time until those class 1 products are CE-marked according to the MDR?
2) If we completely finish the development of our new class 1 products, currently still in the R&D-stage, before 26 May 2020, can we still register them according to the MDD, and not needing notified body authorisation?
Thank very much in advance for your help.