Product Development Flashcards
By when we want to be compliant?
Q3/2019
Who’s involved in the EU/MDR
The whole chain (R&D, Ops, Sales and etc), except for the distributors
By when MDR will be required
26/may/2020
By When IVDR will be required
26/may/2022
What’s EUDAMED
An european database that hold the registration of devices via UDI
UDI?
Unique Device Identification
Common Specification (CS)
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.
What’s Harmonized Standards
It’s in a higher level than the CS and they are not mandatory for Manufacturers (differently than CS)
A software as a medical device is class I unless…
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.
What’s Basic UDI-DI
It’s a primary identifier of a device in a high level manner in EUDAMED.
What’s UDI-DI
identifies the device version and packaging - this is unique in EUDAMED.
What’s UDI-PI
A variable portion of the UDI. This is not saved in EUDAMED.
Will UDI replace other marking or labeling requirements of MDR?
No. It’s an additional.
Who can maintain an UDI for a device?
Only the manufacturer can create and maintain the UDI for a device.
What’s clinical evaluation?
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
What’s clinical investigation?
Is a systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a device
What’s the relation between clinical evaluation and investigation?
Clinical investigation is a subset of clinical evaluation.
Which years the MDD/MDR were created or suffered changes?
1993(MDD), 2005-2010(MDD) and 2010-2017(MDR)
What’s MEDDEV
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.
How often is MEDDEV updated?
Updated regularly
When Revision 4 of MEDDEV was released and what are the highlights?
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
What changes in the area of equivalences in the rev. 4 of MEDDEV?
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.
Who’s responsible for demonstrable Clinical, Technical or Biological equivalences?
Now, the manufacturer must demonstrate that there is no clinically relevant difference between the referenced devices in clinical, technical, and biological properties.
How often a Post-Market Clinical Follow-up (PMCF) must be conducted?
The PMCF is a continuous process to update the clinical evaluation and must be a part of the manufacturer’s Post-Market Surveillance plan.
Does the Post-Market Clinical Follow-up (PMCF) impact in the clinical evaluation?
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.
Clinical Terms - Sponsor
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
Clinical Terms - Clinical Data
Clinical data is information concerning safety or performance that is generated from the use of a device in humans
Clinical Terms - Clinical Evidence
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
Clinical Terms - Clinical Performance
Clinical performance refers to the ability of a device to achieve its intended purpose when used as intended, thereby providing a clinical benefit
Clinical Terms - Clinical Benefit
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
When Clinical investigation is mandatory?
Clinical investigation is compulsory for Class III and for implantable devices. In general, claiming equivalency to another device has become much harder
