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0:00
Hello this is Linda Chatwin and we're going to be talking today about Understanding
the Transition from the Medical Device Directive to the Medical Device Regulation.
0:11
So today our objectives are to go through an overview of
the Medical Device Regulation and then understand
some steps in transitioning from the Medical Device Directive to the Regulation.
We'll talk a little bit about what the notified body requirements are going to be
under this new regulation and how you need to think
about your interactions with the notified bodies.
We'll talk about the UDI being a requirement in the regulation and what
the impact will be on EC certifications.
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So, for an overview,
the regulation was published on May 5th,
this year, and it actually contains about 12 pages of preamble.
Being an attorney, the preamble is quite important to me and it
really contains a lot of information about the rationale of the regulation.
There are 175 pages, including 17 annexes,10 chapters with 123 articles.
Article 123 covers the entry into force and the date of application for the regulation.
So entry into force was on May 26 of this year.
The date of application, meaning,
the last date when everyone must transition to the regulation is May 26, 2020.
The notified body designation can begin in November 17th of this year,
and there are some confidentiality requirements under
the regulation that will go into effect on May 26, 2018.
And finally there's the number of provisions having to do with the EUDAMED database,
which is not actually ready yet.
