The New MDR and IVDR (Ch. 6)

Question 1

What directives does the new EU MDR 2017/745 replace?

Answer 1

1. Medical Devices Directive (MDD, Directive 93/42/EC)

2. Active Implantable Medical Devices Directive (AIMDD, Directive 90/385/EEC)

Question 2

What directive does the new EU IVDR 2017/746 replace?

Answer 2

IVD Directive (IVDD, Directive 98/79/EC)

Question 3

TRUE/FALSE: Some economic operators and devices will be “grandfathered” in under the new regulations.

Answer 3

FALSE

There is no “grandfathering” for products that are already CE-marked, or for notified body designations

Question 4

What were some public health situations that led to the new EU MDR and IVDR?

Answer 4

PIP breast implants, metal-on-metal hip implants, leadless pacemakers, etc. that sparked political wish for more centralized and pre-market controls for higher-risk devices

Question 5

What is included in the scope of the EU MDR?

Answer 5

Medical devices, devices with no medical purpose but with similar risk profile to medical devices, active implantable devices, and products manufactured using human tissues or cells

Question 6

What is the borderline decision mechanism?

Answer 6

Borderline decision mechanism:
Allows the Commission (through the MDCG) to make binding decisions on product qualifications
(both MDR & IVDR)

Question 7

What is the definition of an accessory?

Answer 7

Accessory:

Includes devices that assist a medical device

Question 8

What does MAID stand for?

Answer 8

MAID: Economic operators (of supply chain)
Manufacturer
Authorized Representative
Importer
Distributor

Question 9

TRUE/FALSE: Only the manufacturer has supply chain regulatory obligations.

Answer 9

FALSE
The supply chain controls provide independent regulatory responsibility to each economic operator regarding device compliance, including the obligation to check the previous supply chain link’s compliance

Question 10

What is included in the scope of the EU IVDR?

Answer 10

IVDs, Laboratory-developed tests, companion diagnostics, devices for self-testing, near-patient testing, single-use devices, and kits

Question 11

What does the new traceability system apply to?

Answer 11

All medical devices placed on the EU market, except custom-made or investigational devices

Question 12

What will the UDI be used for?

Answer 12

UDI assigned to individual devices, will be used for reporting serious incidents/FSCAs

Question 13

What is the basic UDI-DI, and what is it used for?

Answer 13

An administrative link, will be used in EUDAMED for product certificates, clinical trial info, periodic safety reports, summary of safety and clinical performance, and vigilance data

Question 14

TRUE/FALSE: Due to the delay of the EUDAMED UDI module, UDI is not required at this time.

Answer 14

FALSE 
UDI is still required to be on products, but there will be a transition period to upload UDI information to EUDAMED when the module is ready

Question 15

What changes in the EU MDR/IVDR affect notified bodies?

Answer 15

• Notified bodies must be re-accredited
• Need more expertise
• Unannounced inspections of mfg. and critical suppliers
• Supporting role in vigilance follow-up

Question 16

What caused most IVDs to require notified body approval?

Answer 16

The new classification rules of the IVDR (no longer a list-based system)

Question 17

TRUE/FALSE: In general, more clinical evidence is required under the MDR/IVDR.

Answer 17

True

Question 18

What is the PRRC, and what is their role?

Answer 18

PRRC: Person Responsible for Regulatory Compliance
Qualification requirements, responsible for managing technical files, Declaration of Conformity, and reporting
(applies to Mfr. and Auth. Reps.)
(may be several people sharing responsibilities)
(does not have to be a company employee)

Question 19

What changes affect post-market surveillance and vigilance?

Answer 19

• Vigilance reporting/FSCA in EUDAMED
• Lifecycle PMS for devices (clinical follow-up plan)
• PSUR: periodic safety update reports
• centralized evaluation of incidents
• Member State cooperation to coordinate enforcement activities
• Binding procedure to deal with noncompliant and compliance devices

Question 20

In the EU MDR, what are the changes affecting classification and conformity assessment?

Answer 20

Minor updates to classification rules

Question 21

In the EU IVDR, what are the changes affecting classification and conformity assessment?

Answer 21

IVD classification system changes from list-based to four risk classes

Question 22

What is the timeline for transitioning to the new EU MDR and IVDR?

Answer 22

Transition Period:
EU MDR: May 2021
EU IVDR: May 2022 
Soft transition / grace period: 
\+3 years

Question 23

What is a delegated act?

Answer 23

Delegated Act:
Non-legislative acts adopted by the European Commission that serve to amend or supplement the non-essential elements of the legislation

Question 24

What is an implementing act?

Answer 24

Implementing Act:

Non-legislative acts and may have individual or general applications

Question 25

What is the purpose of delegated and implementing acts?

Answer 25

To enable the Commission to propose detailed implementing regulation on non-essential issues

Question 26

What are common specifications?

Answer 26

Common Specifications:
A set of technical and/or clinical requirements, other than a standard, that provide a means of complying with the legal obligations applicable to a device, process or system