Hello!
So, item 4 on article 120 of the MDR indicates that "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."
Does this mean that new devices can still get a CE Marking in the period between May 2017 and May 2020 and such devices can be available on the market until 2025?
Our notified body is no longer accepting applications for the MDD, and the queue for the MDR 170 office days! How are you dealing with these timelines?
Item 4 on article 120 of the MDR indicates that "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."
Does this mean that Class I medical devices currently self-declared under MDD 93/42/EEC have until 27 May 2025 to transition to the MDR?
I received notification in early May that my NB was "now" accepting applications, I have a class 1 sterile product , I can't imagine that the review for transition is much more than the sterility aspect as it was for the original application.Sure, new devices can get a CE marking today by either the MDD or MDR or both. This is true until 26 may 2020. After that, devices can only get a CE marking under the MDR. If they are under the MDD and comply with the transition requirements, they can use the CE marking until the certificate is expired 2024). The 2025 date is the one year "sell off" provision of Article 120 Paragraph 4.
Most NBs are not accepting MDD applications anymore because it would take more then 1 year to have a certificate, but would not be able to give a certificate for the MDD after 26 May 2020.
What if I have a current CE that expires in 2022 and chose not to transition. Do I have to pull any product already on the market in 2020 or in 2022?
I received notification in early May that my NB was "now" accepting applications, I have a class 1 sterile product , I can't imagine that the review for transition is much more than the sterility aspect as it was for the original application.