Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

#2
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?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
Place on the EU market = First sale in the EU, either by an EU-based manufacturer or the EU-based importer (not the sale from a non-EU manufacturer to the EU-based importer).
Make available on the EU market = any subsequent sale in the EU, after the placement on the market.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
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?
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.


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?
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.
 
#5
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?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
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?
No, self-declared medical devices have to comply with the MDR in the date of application (May 2020). Only class I M or S device (which have a valid certificate) may continue to be put into the market under the MDD.
 
#7
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?
 
#8
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.
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.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#9
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?
If you have a valid CE certificate and comply with the requirements for maintaining a valid certificate, you can put products in the market until the end of the certificate validity. Please note that you do not need to pull products off the market.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#10
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.
This really depends on how busy the NB is.
 
Top Bottom