Report on
EU IVD Regulation Seminar
Reported by Yoko Sugiyama (HORIBA, Ltd)
Date and time:14：30～16：30, Nov. 11, 2016
Place:TKP Ochanomizu Conference Center
We have organized the seminar for our membership companies about the EU
IVD Regulation (IVDR) by Mr. Jesus Rueda Rodriguez, who is the Regulatory
Director of EDMA (European Diagnostics Manufactures Association) and who isworking on IVDR which will be issued in 2017.
117 members joined this seminar and it was very successful.
Here you can find the summary of his presentation.
The latest draft of IVDR has around 300 pages and more than 100 items might
affect the manufacturers.

The two most influential added items are following:“Advertising” and “Authorized Representative Liability”.
<Basic Scheme on regulatory process>There is no change on the basic schemeof the regulatory process; however, it
will be defined in more detail anddetailed rules will be added.

Product Design
The requirements for Product Design will be based on the current directive(IVDD), and mostly it will follow GHTF (Global Harmonization Task Force)
requirements. Some new requirements are added which are related to the newtechnologies that have been developed in these twenty (20) years. For example,
Design management for Software Usability, some requirements about Near
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Patient testing. In addition, the risk management will be based on the bestpractice of ISO14971.
Evidence
One of the most important things is that “Evidence” on the performance andsafety is required by IVDR

to finally declare conformity andto have CEmarking.
There are 3 Clinical Evidences; Analytical Performance, Clinical Performance,
and Scientific Validity. The way of collecting these evidences and how to organize
the clinical testing are also mentioned in IVDR. Of course, EMC (ElectromagneticCompatibility), Chemical Safety, Biological Safety, which is currently regulated,will be also regulated, as well.
Conformity Assessment
The Conformity Assessment of each product will be changed. Classification will
be A, B, C and D which is same as GHTF. The highest risk from the view point ofpatient is “class D”, and the lowest risk is “class A”. Notified bodies, Referencelaboratories will depend on the classification of each product.
Registration
All the Manufacturer and Products will be registered on the new data base called“EUDAMED” which is now under development. The manufacturers will beresponsible for the maintenance of the data. Each Manufacturer will have its
unique “Single Registration Number “(SRN)” and it will be registered on“EUDAMED”. As for the products, each product will have “Unique Device
Identification（UDI）” and it will be also registered on “EUDAMED”.
CE Marking
CE marking process is unchanged.
Post Market Follow up- Vigilance
Reporting Timeline after Adverse event goes from 30 to 15 days and the reports
will be uploaded via EUDAMED.
In addition, Post market performance follow-up (PMPF) needs to be planned and
PMFP will need to be audited by notified bodies.
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In addition to the regulatory process, the items about “Transparency” will beadded. All the information about “Vigilance”, “Summary device performance“,and “Summary of studies” will be disclosed.
“Manufacturers” need to sign up the insurance or reserves to cover liability.
Furthermore, “Authorized Representative” will have to be liable for products
placed on the EU market. They will have to keep “Technical File”, and they will
have to give it to the regulatory authority in accordance with their request.
Finally, all the transition period to IVDR will be five (5) years (sixty 60 months)
from the issued date.

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