EU

Question 1

Which Directive does the MDR replace?

Answer 1

• 93/42/EC MDD

- 90/385/EEC AIMDD

Question 2

Which Directive does the IVDR replace?

Answer 2

98/79/EC

Question 3

What statement used throughout the MDR ensures gradual replacement of older products with more modern medical devices?

Answer 3

“state of the art”

Question 4

Does the MDR cover products to which the manufacturer does not claim an intended medical purpose, but the product may share risk profile with a medical device?

Answer 4

Yes

Question 5

Which Annex contains a list of products to which a manufacturer does not intend to have a medical purpose but will be required to maintain compliance as a medical device under the MDR?

Answer 5

Annex XVI

Question 6

Are medical device accessories classified in their own right?

Answer 6

Yes, except for AIMDD device accessories which will automatically be Class III along with the parent device

Question 7

Which Commission group under the MDR can now make binding decisions on product qualification?

Answer 7

Medical Device Coordination Group (MDCG)

Question 8

What are the 4 types of IVD families which the IVDR provides specific definition and regulatory requirements on?

Answer 8

• Devices for self-testing
• Devices for near-patient testing
• Single-use devices
• Kits

Question 9

What is an accessory within the scope of the MDR?

Answer 9

Anything that “assists” a medical device

Question 10

Will products used for cleaning, sterilizing, or disinfecting medical devices be considered accessories under the MDR?

Answer 10

No, they will be considered medical devices under the MDR

Question 11

What is MAID?

Answer 11

Manufacturer, Authorized Rep, Importer, Distributor; MAID are the economic operators according to the new MDR supply chain regime

Question 12

Under the MDR, which economic operators have regulatory requirements?

Answer 12

All MAID

Question 13

Do Authorized Reps under the MDR carry liability for defective devices?

Answer 13

Yes

Question 14

What is the overarching EU IT architecture for administrating medical devices under the new regulations?

Answer 14

Eudamed

Question 15

Do manufacturers have to comply with UDI requirements if Eudamed is not operational in time?

Answer 15

Yes, they are expected to implement UDI by the implementation date and store this information to retroactively load within the Eudamed database once it is operational

Question 16

How are NBs expected to assist in the enforcement of the new regulation?

Answer 16

Unannounced audits of manufacturing facilities and increased involvement with vigilance reporting

Question 17

Are most IVD no longer allowed to be self certified under the MDR?

Answer 17

Yes, where previously only 10-20% required CE-cert by a NB, 80-90% will now

Question 18

In what instance can a CE listed device currently not reuired to have clinical evidence to support its CE mark forego clinical evidence requirements under the MDR?

Answer 18

Never, as the MDR will not allow any devices to be “grandfathered” into the MDR

Question 19

Will existing clinical data collected under the MDD and AIMDD be used for supporting CE certification under the MDR?

Answer 19

Yes, but only if it meets the requirements of the new regulation

Question 20

What are the new aspects of both regulations regarding the Common Specifications adoption mechanism?

Answer 20

• General safety and performance requirements
• Technical documentation
• Clinical evaluation
• Postmarket clinical followup or clinical investigation

Question 21

When can a Common Specification be adopted?

Answer 21

When there is no harmonized standard or a harmonized standard is insufficient

Question 22

How many risk classifications are there for IVDs under the IVDR and who proposed the system?

Answer 22

There will be 4 classes: A-D based on the GHTF

Question 23

What impact do the new EU regulations have on Own Brand Labeling (OBL)?

Answer 23

Where previously, a manufacturer could get by with an abbreviated TF for authorities, they will now be required to have a complete TF for each device

Question 24

When is a nation under the scope of the new EU regulations required to follow common conformity paths for reprocessing of single use medical devices?

Answer 24

Once they allow single use reprocessing

Question 25

Who is the Medical Device Coordination Group (MDCG) comprised of?

Answer 25

Member State delegates with medical device and IVD expertise and chaired and support by the Commission

Question 26

How does the MDCG make decisions?

Answer 26

Consensus/majority vote

Question 27

Assessing applicant NBs and their periodic accreditation renewals, high risk device conformity assessment, guidance on effective and harmonized regulation implementation, oversight of expert panels and laboratories, and developing the EU market surveillance program are all responsibilities of what organization?

Answer 27

MDCG

Question 28

Who should be consulted when dealing with the application of procedures for noncompliant devices?

Answer 28

MDCG