Enforcement and Competent Authorities (Ch. 4)

Question 1

What authority is responsible for drafting medical regulations?

Answer 1

The EU Commission (With help from the Member States and EU Parliament)

Question 2

What authority is responsible for market oversight and enforcement of regulations?

Answer 2

Competent Authorities

Question 3

TRUE/FALSE: Relevant competent authorities must grant permission prior to a clinical investigation beginning.

Answer 3

True

Question 4

What are the terms for a clinical trial, investigation, and performance study applicable to?

Answer 4

Clinical Trial = Pharmaceutical
Clinical Investigation = Medical Device
Performance Study = IVD

Question 5

What authorities are required to cooperate and coordinate for effective medical device enforcement?

Answer 5

Member State Competent Authorities, Notified Bodies, and the European Commission

Question 6

What does “wrongly affixed CE marking” mean?

Answer 6

Wrongly affixed CE marking:
When the CE mark is affixed to a device that is not in conformity with the legal requirements (a non-compliant device), or when the CE mark is affixed to products that do not fulfil the definition of a medical device
(MDD Article 18)

Question 7

What is the safeguard clause?

Answer 7

Safeguard Clause:
gives Member States the legal power to act without delay on conforming devices that pose an unacceptable health risk
(MDD Article 8)

Question 8

What is “particular health monitoring measures”?

Answer 8

Particular health monitoring measures:
A Member State can act against more general threats to public health
(MDD Article 14b)

Question 9

What is the definition of market surveillance (MDD)?

Answer 9

Market Surveillance:
Comprises executed activities and CA’s measures to check and ensure devices present within their national territories comply with the directives’ requirements
(MDD Article 10)

Question 10

What is postmarket surveillance (PMS)?

Answer 10

Postmarket surveillance (PMS):
A systematic and proactive process to collect and review experience gained from the manufacturer's devices on the market

Question 11

What is vigilance reporting?

Answer 11

Vigilance:

Manufacturers are required to notify the relevant CAs of serious incidents and FSCA

Question 12

TRUE/FALSE: Market surveillance, postmarket surveillance, and vigilance reporting are the responsibility of the manufacturer.

Answer 12

FALSE
Market surveillance = CA
PMS and vigilance = Manufacturer

Question 13

What is the MEDDEV 2.12/1?

Answer 13

MEDDEV 2.12/1: Guidelines on a Medical Devices Vigilance System
Outlines the steps manufacturers, CA’s, and other entities need to take regarding market surveillance, PMS, and vigilance

Question 14

What is the purpose of EUDAMED?

Answer 14

To facilitate the exchange of information and communication via central database

Question 15

What will the new EUDAMED (under MDR/IVDR) include?

Answer 15

Economic operator information, products and certificates, PMS, and clinical investigations

Question 16

What is the main responsibility of a Notified Body?

Answer 16

Notified Body:
Check manufacturers’ medical device premarket conformity assessments, by issuing certificates (may also withdraw or suspend as necessary)

Question 17

TRUE/FALSE: The EU MDR/IVDR extend the post-market enforcement role to Notified Bodies.

Answer 17

True - Notified Bodies now have more responsibilities regarding postmarket activities

Question 18

What are GMPs?

Answer 18

GMP: Good Manufacturing Practice

The minimum standards that a medicinal product manufacturer must meet in its production processes

Question 19

What is the EU GMP directive?

Answer 19

Commission Directive 2003/94/EC

Question 20

What is pharmacovigilance?

Answer 20

Pharmacovigilance:

The process of monitoring medicinal products’ use after they have entered the market

Question 21

What is the definition of a competent authority?

Answer 21

Competent Authority (CA): 
A regulatory body for market oversight and enforcement in a Member State