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
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2. MAIN CHANGES
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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

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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

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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.

5. PURPOSE
SCOPE
DEFINITIONS
Overview of objectives and scope of rules
defined in this regulation required to place
medical devices on the EU market
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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
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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
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26 May 2020

8. OUT OF SCOPE
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 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
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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
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 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
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 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

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