This document summarizes the new requirements for clinical evaluations and investigations under the upcoming EU Medical Device Regulation (MDR). Some key points: - The MDR introduces stricter rules for clinical evaluations and investigations that will require manufacturers to consult expert panels and provide more clinical data to demonstrate safety and performance. - Clinical evaluations must generate and assess clinical data from the manufacturer's own investigations as well as data from competitors or pre-clinical tests. - Clinical investigations will be mandatory for high-risk Class III devices and implantables, except under certain conditions where equivalence to existing devices can be shown. - Notified bodies will have between 10-75 days to approve clinical evaluation reports and compliance with the new

1. 4 October 2017
IMPACT OF THE NEW EU MEDICAL
DEVICE REGULATION (MDR) ON
CLINICAL EVALUATIONS AND
INVESTIGATIONS
MEDTECH, Informa, Amsterdam June 2017

2. 2
Agenda
• Introduction
• Clinical Evaluation
• Clinical Investigation
• Conclusion

3. 3
Definitions
Clinical Evaluation Clinical Investigation/Trial
A systematic and planned
process to continuously
generate, collect, analyze and
assess the clinical data
pertaining to a device in order to
verify the safety and
performance, including clinical
benefits, of the device when
used as intended by the
manufacturer.
Systematic investigation
involving one or more human
subjects, undertaken to
assess the safety or
performance of a medical
device.

4. 4
MDR Implementation Timelines
MDR
Publication
MDR
Implementation
Report on MDR
implementation
MDR
Revision?
Transition Period (3y) Pilot Period (7 y)
EUDAMED
availability
May 2017 May 2020 May 2025 May 2027

5. 5
New Requirements:
• Class IIb and III => Consultation of expert panel for confirmation of the clinical
development strategy*.
• Availability of “Sufficient” clinical data
- Should be from the manufacturer own clinical data
- Can be from “competition” but in that case a contract must be available to justify
access to the clinical data
- Can be from Pre-clinical test
* Mandatory for implantable class III and active IIb

6. 6
Special cases high risk profiles
• If class III or implantable device: Clinical investigation is mandatory
except if the following 3 conditions are met
- Modified device is from the same manufacturer
- Modified device is equivalent to the marketed one (validated by NB)
- Clinical evaluation is able to demonstrate conformity with safety and performance
requirement.
- Exception of this rules : suture, staples, dental filing, dental braces, tooth
crowns, screws, wedges, plates, wires, pins, clip or connector.
• Implantable MD: clinical evaluation summary (safety and perf) should be
publicly available
 PMCF studies mandatory for safety and performances

7. 7
Main changes
• Clear reference of ISO14155
- Only MD or Dentist (qualified and trained)
- Requirement for legal representative
- Subject for CI are independent from Investigator
- Risk management process
• Pilot period of 7 years; based on voluntarily participation from member states
• Study report summary to be produce should be easily understandable  public
access
• Safety reporting must avoid double reporting for post market device in clinical
investigation

8. 8
Application process – initial submission
New timelines based on product profile
10 d
is CTA complete?
Approbation related to
EC/IRB approval
10 -20 d
file completion
5 d
is CTA complete?
45 d CTA evaluation
Extra 20 d
if expert consulted
Between 10 to 75 days for final approval by NCA
Sponsor question
mgmt. (12 d)
EC/IRB process must end before this period
Submission
No
Class III or
implantable
class II
Class I or
non invasive
class II
Note: in case of multiple country submission, an extra 6 days for validating the coordinating MS will be applied
Yes
Yes
Yes
Yes
NCA
Sponsor

9. 9
Take home messages
• It is time to start collecting clinical data
• Update your SOPs
• Identify your Responsible Person
• Update your PMS rules
• Risk management
• Data protection...
• Check if your clinical evaluation data comply with new requirements
• Special attention : CE marked devices based on equivalence process
 Ask the question:
“Do I have full access to clinical data used to support the claim”

10. 10
Find full presentation and other useful content on how to use regulatory
strategy to accelerate your healthcare product development on
www.voisinconsulting.com
Get in touch with VCLS regional team in Paris, London, Lausanne,
Redwood City, Cambridge, Somerville