Product Development

Question 1

By when we want to be compliant?

Answer 1

Q3/2019

Question 2

Who’s involved in the EU/MDR

Answer 2

The whole chain (R&D, Ops, Sales and etc), except for the distributors

Question 3

By when MDR will be required

Answer 3

26/may/2020

Question 4

By When IVDR will be required

Answer 4

26/may/2022

Question 5

What’s EUDAMED

Answer 5

An european database that hold the registration of devices via UDI

Question 6

UDI?

Answer 6

Unique Device Identification

Question 7

Common Specification (CS)

Answer 7

Common Specifications refer to a mandatory set of technical and/or clinical requirements for fulfilling the legal obligations applicable to a device, process, or system.

Question 8

What’s Harmonized Standards

Answer 8

It’s in a higher level than the CS and they are not mandatory for Manufacturers (differently than CS)

Question 9

A software as a medical device is class I unless…

Answer 9

Used to make diagnostic or therapeutic decisions, classified based on impact of the decision. Class IIa by default, but can go up to Class III
Intended to monitor physiological process, Class IIa by default but can go up to Class IIb.

Question 10

What’s Basic UDI-DI

Answer 10

It’s a primary identifier of a device in a high level manner in EUDAMED.

Question 11

What’s UDI-DI

Answer 11

identifies the device version and packaging - this is unique in EUDAMED.

Question 12

What’s UDI-PI

Answer 12

A variable portion of the UDI. This is not saved in EUDAMED.

Question 13

Will UDI replace other marking or labeling requirements of MDR?

Answer 13

No. It’s an additional.

Question 14

Who can maintain an UDI for a device?

Answer 14

Only the manufacturer can create and maintain the UDI for a device.

Question 15

What’s clinical evaluation?

Answer 15

Is a systematic and planned process to continuously generate, collect, analyze, and assess clinical data pertaining to a device in order to verify how safe it is and how effectively it performs

Question 16

What’s clinical investigation?

Answer 16

Is a systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a device

Question 17

What’s the relation between clinical evaluation and investigation?

Answer 17

Clinical investigation is a subset of clinical evaluation.

Question 18

Which years the MDD/MDR were created or suffered changes?

Answer 18

1993(MDD), 2005-2010(MDD) and 2010-2017(MDR)

Question 19

What’s MEDDEV

Answer 19

The European Commission and Competent Authorities (CAs), assisted by stakeholders, draft a range of guidance documents, called MEDDEV. These documents assist stakeholders in implementing Directives related to medical devices.

Question 20

How often is MEDDEV updated?

Answer 20

Updated regularly

Question 21

When Revision 4 of MEDDEV was released and what are the highlights?

Answer 21

2016.

Highlights of MEDDEV 2.7.1 Revision 4
“Sufficient Clinical Evidence” as a key concept

Clinical evaluation as an ongoing process throughout the life cycle of the device

Requirement of Clinical Evaluation Report (CER) for all classes of devices

Inclusion of usability requirements

Required qualifications of clinical evaluators

Greater focus on analysis and appraisal of data

Requirement of regular updates of the CER

Guidance on additional clinical investigations and unmet medical needs

Elaborate, systematic description of the clinical evaluation process, including post-market clinical follow up

Question 22

What changes in the area of equivalences in the rev. 4 of MEDDEV?

Answer 22

Clinical equivalence
The device has the same clinical application at the same site in the body, in a similar population, with a similar performance, and with the same kind of user.

Technical equivalence
The device is similar with regard to design, specifications, and properties; conditions of use; principles of operation; and critical performance requirements.

The device uses the same materials for a similar contact location and with similar release properties.

Question 23

Who’s responsible for demonstrable Clinical, Technical or Biological equivalences?

Answer 23

Now, the manufacturer must demonstrate that there is no clinically relevant difference between the referenced devices in clinical, technical, and biological properties.

Question 24

How often a Post-Market Clinical Follow-up (PMCF) must be conducted?

Answer 24

The PMCF is a continuous process to update the clinical evaluation and must be a part of the manufacturer’s Post-Market Surveillance plan.

Question 25

Does the Post-Market Clinical Follow-up (PMCF) impact in the clinical evaluation?

Answer 25

Yes. The clinical evaluation and its documentation must be updated throughout the life cycle of the device with clinical data derived from implementation of the manufacturer’s PMCF.

Question 26

Clinical Terms - Sponsor

Answer 26

A sponsor is any individual, company, institution or organization which takes responsibility for the initiation, management and setting up of the financing of the clinical investigation

Question 27

Clinical Terms - Clinical Data

Answer 27

Clinical data is information concerning safety or performance that is generated from the use of a device in humans

Question 28

Clinical Terms - Clinical Evidence

Answer 28

Clinical evidence is clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended

Question 29

Clinical Terms - Clinical Performance

Answer 29

Clinical performance refers to the ability of a device to achieve its intended purpose when used as intended, thereby providing a clinical benefit

Question 30

Clinical Terms - Clinical Benefit

Answer 30

Clinical benefit refers to the positive impact on health, expressed as meaningful, measurable, and relevant clinical outcome(s), including a positive impact on patient management or public health

Question 31

When Clinical investigation is mandatory?

Answer 31

Clinical investigation is compulsory for Class III and for implantable devices. In general, claiming equivalency to another device has become much harder