Chapter 7: Clinical Evaluation and Clinical Investigations

Question 1

(T/F) A clinical evaluation is required for only Class III devices

Answer 1

False, A clinical evaluation is required for every device (class I, II, III) under all directives (AIMDD, MDD, IVDD)

Question 2

(T/F) The Clinical Evaluation Report (CER) must be updated actively throughout the device’s lifecycle as an ongoing process

Answer 2

True

Question 3

(T/F) The MDD specifies the clinical evaluation to be updated every 2-5 yrs

Answer 3

False, the MDD does not specify the clinical evaluation update frequency

Question 4

Updates to the CER should be made with data obtained from _____ _____ _____.

Answer 4

Updates to the CER should be made with data obtained from (Post Market Surveillance).

Question 5

What MEDDEV defines guidance on clinical evaluations?

Answer 5

MEDDEV 2.7/1 rev 4

Question 6

When should the CER be actively updated?

Answer 6

1. When Mfg. receives new PMS information that has the potential to change the current evaluation
2. At least annually if the device carries significant risk or is not yet well established
3. Every two or five years if the device is not expected to carry significant risk and is well established, justification should be provided

Question 7

For Class III and Implantable devices, when does the MDR specify that the PMCF (Post market clinical follow-up) report shall be updated?

Answer 7

at least annually; indicating the CER needs at least an annual update

Question 8

Necessity for clinical evaluation under the MDR to provide more rationale for the product…

Answer 8

consideration of currently available alternative treatment options for that purpose, if any

Question 9

Class ____ and _____ devices will need to critically review their current clinical evaluations and the amount and quality of the clinical data

Answer 9

Class (3) and (implantable) devices will need to critically review their current clinical evaluations and the amount and quality of the clinical data

Question 10

(T/F) Under MDR, demonstrating equivalence to a competitors device’s clinical literature will become much easier, specifically for Class III and implantable devices

Answer 10

False, if a Mfg. wishes to demonstrate equivalence to a already marketed device, not manufactured by itself, to avoid performing a clinical investigation…..

The two manufacturers must have a contract in place that explicitly allows full access to the marketed device’s technical file on a continuous basis, including PMS, covering both Annex II and Annex III technical documentation

Question 11

What is the first step of performing a clinical evaluation?

Answer 11

Clinical evaluation plan

Question 12

To make current CE-marked products MDR complaint, to determine how to collect clinical data, or to get clinically in shape with its full product portfolio, setting up a ______ ______ can be very helpful for a manufacturer

Answer 12

Clinical strategy

Question 13

ISO _____ and ___ ______ best define the elements included in the clinical investigations

Answer 13

ISO (14155) and (MDR Annex XV) best define the elements included in the clinical investigations

Question 14

Clinical Trial Essentials

Answer 14

Pg 77

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