EU Flashcards
Which Directive does the MDR replace?
- 93/42/EC MDD
- 90/385/EEC AIMDD
Which Directive does the IVDR replace?
98/79/EC
What statement used throughout the MDR ensures gradual replacement of older products with more modern medical devices?
“state of the art”
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?
Yes
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?
Annex XVI
Are medical device accessories classified in their own right?
Yes, except for AIMDD device accessories which will automatically be Class III along with the parent device
Which Commission group under the MDR can now make binding decisions on product qualification?
Medical Device Coordination Group (MDCG)
What are the 4 types of IVD families which the IVDR provides specific definition and regulatory requirements on?
- Devices for self-testing
- Devices for near-patient testing
- Single-use devices
- Kits
What is an accessory within the scope of the MDR?
Anything that “assists” a medical device
Will products used for cleaning, sterilizing, or disinfecting medical devices be considered accessories under the MDR?
No, they will be considered medical devices under the MDR
What is MAID?
Manufacturer, Authorized Rep, Importer, Distributor; MAID are the economic operators according to the new MDR supply chain regime
Under the MDR, which economic operators have regulatory requirements?
All MAID
Do Authorized Reps under the MDR carry liability for defective devices?
Yes
What is the overarching EU IT architecture for administrating medical devices under the new regulations?
Eudamed
Do manufacturers have to comply with UDI requirements if Eudamed is not operational in time?
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
How are NBs expected to assist in the enforcement of the new regulation?
Unannounced audits of manufacturing facilities and increased involvement with vigilance reporting
Are most IVD no longer allowed to be self certified under the MDR?
Yes, where previously only 10-20% required CE-cert by a NB, 80-90% will now
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?
Never, as the MDR will not allow any devices to be “grandfathered” into the MDR
Will existing clinical data collected under the MDD and AIMDD be used for supporting CE certification under the MDR?
Yes, but only if it meets the requirements of the new regulation
What are the new aspects of both regulations regarding the Common Specifications adoption mechanism?
- General safety and performance requirements
- Technical documentation
- Clinical evaluation
- Postmarket clinical followup or clinical investigation
When can a Common Specification be adopted?
When there is no harmonized standard or a harmonized standard is insufficient
How many risk classifications are there for IVDs under the IVDR and who proposed the system?
There will be 4 classes: A-D based on the GHTF
What impact do the new EU regulations have on Own Brand Labeling (OBL)?
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
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?
Once they allow single use reprocessing
