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Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
1. Medical
Device
Regulation
2017/745
Regulation (EU) 2017/745 of 5 April 2017
on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002
and Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC
and 93/42/EEC
PAGE 1
2. MAIN CHANGES
PAGE 2
Product scope
expansion
Implementation of
Unique Device
Identifier (UDI)
Post-market
surveillance
Person responsible for
regulatory compliance
Common
specifications
Reclassification of
devices to account for
risk, contact duration
and invasiveness
Clinical evidence for
class III and
implantable devices
Systematic clinical
evaluation of IIa and
IIb
No grandfathering
provisions
3. PAGE 3
Scope & Definitions
Placing devices on the EU market
Identification & traceability
Notified bodies
Classification & Conformity
assessment
Clinical Evaluations & Clinical
Investigations
Post-market surveillance & Vigilance
Cooperation between member states
Confidentiality, data protection,
funding, penalties
Annexes
4. PAGE 4
The risk management system should be carefully
aligned with and reflected in the clinical evaluation
for the device, including the clinical risks to be
addressed as part of clinical investigations, clinical
evaluation and post-market clinical follow up. The
risk management and clinical evaluation processes
should be inter-dependent and should be regularly
updated.
Amen.
6. PURPOSE
All medical devices other than in vitro
Free movement of goods, parallel trade
Borderline cases decided on case by case basis
Clinical evaluation, vigilance and post-market surveillance
Authorized representative for manufacturers not established in the EU
Traceability using Unique Device Identification system (UDI)
Summary of safety and clinical performance
Conformity assessment
Clinical investigations
Adverse incidents and field safety corrective actions
PAGE 6
7. SCOPE
Medical devices for human use
Placing devices on the market, making them available, putting them into service
Devices w/o medical purpose listed in Annex XVI shall comply with Annex I requirements
Contact lenses, dermal fillers,
Equipment for liposuction,
High-intensity EM radiation, equipment for brain stimulation
Devices that incorporate an in vitro device, medicinal product, product derived from human
blood or plasma, non-viable cells and tissues, if these components are integral part of the
device and only have ancillary function
Clinical investigations for products covered by this Regulation
PAGE 7
26 May 2020
8. OUT OF SCOPE
PAGE 8
Combination products where the component other than device has
principal function
In vitro devices
Medicinal products
Advanced therapy products
Human blood, plasma, cells
Cosmetics
Transplants, cells and tissues (animal, human)
Biological material or viable organisms
Food
26 May 2020
9. DEFINITIONS
Medical device means any instrument, apparatus, appliance, software, implant, reagent,
material or other article intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the following specific medical purposes:
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
investigation, replacement or modification of the anatomy or of a physiological or pathological
process or state,
providing information by means of in vitro examination of human specimens
devices for the control or support of conception;
products specifically intended for the cleaning, disinfection or sterilization of devices
PAGE 9
10. DEFINITIONS
Accessory for a medical device
Custom-made device
Mass-produced device
Active device (incl. software)
Implantable device
Invasive device
Generic device group
Single-use device
Falsified device
Procedure pack
System
PAGE 10
Clinical evaluation
Clinical investigation
Investigational device
Clinical investigation plan
Clinical data
Sponsor
Subject
Clinical evidence
Clinical performance
Clinical benefit
Informed consent
Intended purpose
Label
Instructions for use
Unique Device Identifier (UDI)
Risk
Benefit-risk determination
Compatibility
Interoperability
Authorized representative
Notified body
11. DEFINITIONS
Non-viable
Derivative
Nanomaterial
Particle
Agglomerate
Aggregate
Performance
Reprocessing
Corrective action
Field safety corrective action
Field safety notice
PAGE 11
Conformity assessment
Conformity assessment body
CE marking of conformity
Common specifications
Harmonized standard
Device deficiency
Post-market surveillance
Market surveillance
Recall
Withdrawal
Incident
Serious incident
Serious public health threat
Making available on the market
Placing on the market
Putting into service
Manufacturers
Fully refurbishing
Importer
Distributor
Economic operator
Health institution
User
Lay person