Medical Device Regulation Conformity Routes
2www.be-on-quality.com
The goal is to ensure a simple and easy to understand
regulatory environment for medical devices, which ensures the
efficient functioning of the internal market.
3www.be-on-quality.com
follow-upconformity assessment procedure
risk management
usability
Classification
of the medical
product
Clinical
Evaluation
General safety
and performance
requirements
Technical
DocumentationCE marking
Post market
Surveillance
Quality
management
system
idea market
4www.be-on-quality.com
Annex III Documentation on Post Market
Surveillance
Annex IV Declaration ofconformity
Annex II Technical
Documentation
Annex VIUDI - Unique
Device Identification
Annex IGeneral Safety
and Performance Requirements
Annex VIII Classification
Rules
Certification?
5www.be-on-quality.com
Intended
purpose
Classification
Clinical data
Risk
management
General safety
and
performance
requirements
UDI
PMCF
PMS Common specifications
CER
6www.be-on-quality.com
INTENDED PATIENT
POPULATIONThe DEMOGRAPHICS of the patient
INTENDED USERWHO should use the device
INTENDED USEHOW to use the device
PRINCIPLES OF OPERATIONHOW the device achieves its Intended Purpose
INDICATIONS FOR USEThe CLINICAL PICTURE of the patient
Contraindications
CLAIMSWHAT the device does• Prevention• Diagnosis/Prognosis (Support)• Management/Monitoring• Treatment/Alleviation• Predicate Device
7www.be-on-quality.com
class I class I s / m / r class IIa class IIb class III
Annex I - General Safety and Performance RequirementsAnnex II - Technical DocumentationAnnex III - Documentation on Post Market SurveillanceAnnex VI - UDI - Unique Device Identification
Annex VIII - Classification Rules
8www.be-on-quality.com
Risk
class
low medium high
Class I Class IIa Class IIb Class III
According to risk-based rules (e.g. EU) or lists (e.g. USA)
9www.be-on-quality.com
Intended use of the device
Non-active medical device Active medical device Special rules
Invasive medical devices
Non-Invasive medical devices
Type and duration of invasiveness
III
II a/ b
I s m r
10www.be-on-quality.com
non-invasive devices
Rule 3modifying
biological or chemical
composition
Rule 2channelling or storing blood
Rule 1
Rule 4contact with injured
skin or mucous membrane
invasive devices
Rule 8implantable
devices
Rule 7short-
term use
Rule 6transient
use
Rule 5not intended for connection to an active device or intended for
connection to class I
active devices
Rule 12intended to
administer or remove medicinal
products
Rule 11software
Rule 10devices intended for diagnosis and
monitoring
Rule 9therapeutic devices
intended to exchange energy
Rule 13
special rulesRule 18
tissues or cells of human or animal origin
Rule 16devices intended to disinfect contact
lenses
Rule 15contraception
Rule 14devices incorporating a medicinal product
Rule 17devices for
recording x-ray diagnostic images
Rules 19nanomaterial
Rule 20inhalation
Regel 21combination of substances
Rule 22closed loop systems
11www.be-on-quality.com
Device + software
Not invasive
Short term
Not invasive
Radiation
Transient
Long time
Invasive
Not active
12www.be-on-quality.com
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+
EU
Declaration
of
Conformity
Annex IV
Manufacturer assigns
I
13www.be-on-quality.com
product conformity testing
Annex XI
Manufacturer assigns
IIa
xxxx
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+
IIa
Costs: 20k€
14www.be-on-quality.com
product conformity testing
Annex XI
Manufacturer assigns
IIb + III
xxxx
type examination
Annex X
IIb + III
+
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+
Costs: 20k€
Costs: 10k€
per Batch
15www.be-on-quality.com
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+
CompleteQMS
Annex IX
Manufacturer assigns
I + IIa + IIb
+ III
xxxx
Costs: 20k€
Each Scope:
15k€
16www.be-on-quality.com
product conformity testing
Annex XI
Manufacturer assigns
IIa + IIb + III
xxxx
type examination
Annex X
IIb + III
+
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+ ++
+
IIa
EU
Declaration
of
Conformity
Annex IV
Manufacturer assigns
I
CompleteQMS
Annex IX
Manufacturer assigns
I + IIa + IIb
+ III
xxxx
Costs: 10k€
per Batch
Costs: 20k€ Costs: 20k€
Each Scope:
15k€
17www.be-on-quality.com
product conformity testing
Annex XI
Manufacturer assigns
IIa + IIb + III
xxxx
type examination
Annex X
IIb + III
+
QMS referred to in Article 10(9)
+
Preparation of the technical documentation according to Annex II + III
+ ++
+
IIa
EU
Declaration
of
Conformity
Annex IV
Manufacturer assigns
I
CompleteQMS
Annex IX
Manufacturer assigns
I + IIa + IIb
+ III
xxxx
Costs: 10k€
per Batch
Costs: 30k€Costs: 20k€
Medical Device Regulation Performing the Conformity Assesmsent
19www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
20www.be-on-quality.com
Roles
NotifiedBody
Authorities
EU-Commission
Manufacturer
SupplierImporter
Distributor
Marketplace
Represent-ative
Critical Suppliers
and outsourced
services only
21www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
Internal Step at the
notified body
22www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
23www.be-on-quality.com
Section 1:
Names,
Addresses,
Identification,
Conformity
Economic
Operators
Section 2 –
Relevant
Regulations
and Technical
Standards
Standards
Common
Specifications
Section 3 –
Description of
Device
Intended
purpose
Claims
Section 4 –
Labels and
Labeling
UDI
MD-Symbol
IFU
Section 5 –
Bench Testing
and Clinical
Data
Summary
CEP, CER,
PMCF
PMS & PSUR
Section 6 –
Risk Analysis
Summary
Risk Benefit
discussion
Section 7 –
Technical
infomation
Specification
Architecture
Verification
and Validation
24www.be-on-quality.com
Declaration of
conformity
ISO 13485MDR Article 10.9
Risk Management Plan
Risk analysis
Use specification
Summative Evaluation
Formative Evaluation
Development –Test
PlanSW and EMC
User Requirements
Product Requirements
SW
design
Design Release
Validation
Literature Search
Clinical Evaluation Plan
Label
Electronic and
mechanical
design
Intended PurposeGSPR
25www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
26www.be-on-quality.com
Step by step to QMS certification
1 • Building awareness for quality management
2 • Inventory and formulation of objectives
3 • QM documentation
4 • staff training
5 • Internal Audit
6 • management review
7 • certification
27www.be-on-quality.com
Production
Thu
checkact
scheme
MDR-QMS
quality management manual
4. quality management system
5. management responsibility
6. management of resources
documentaryrequirements
Technicaldocumentation
Human Resources
7. product realization
Supplier management
External communication
Development
Clinical life cycle Risk management
software development
Identification and traceability
analysis and management evaluation
Post-market monitoring
Improvement
Complaints and feedback
Vigilance
Quality audit
Corrective and preventive measures
8. measurement, analysis and
improvement
Development changes
28www.be-on-quality.com
Timeline for the creation of a QMS
Directives, laws and standards
EN ISO 13485
MDR 2017/745
QM specification documentation
lawsuits
templates
quality records
Documents (changeable)
records(not changeable)
e.g. completed protocols, reports, plans
29www.be-on-quality.com
QMS setup
quality policy
process landscape
(QMH and Processes)
templates
Quality records and
documents
• "soul" of the QMS
• Q policy usually public ("corporate values")
• New employees find their way around quickly
• Consistent workflows
• "Small consultant" for document creation
• You don't always have to think of everything
yourself
• Actual documentation
• Required by the quality management system
30www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
31www.be-on-quality.com
Certificate
Preparation
Contact
approvals
Technical File
Assessment
Stage 1 QMS
Stage 2 Audit
Certification
check and
notified
body
internal
assessment
MDR TD compilation
34www.be-on-quality.com
Compile the perfect file
Annex II
Annex III
GSPR
35www.be-on-quality.com
Remove formatting
issues
Ensure all Documents
to besigned
CompileGSPR First
Ensure all standardsused to be
valid
EnableOCR and make is
searchable
Create Annex II
and Annex III
Compilethem all intoONE BIG,
BIG document
MDR Common mistakes
37www.be-on-quality.com
DECLARATION OF INTEREST
(CER)
VIGILANCE PROCEDURE
PMCF NOT DETAILED
RISK BENEFIT WITHOUT CER
LABELLING
TYPE TEST
BIOLOGICAL ASSESSMENTS
STATE OF THE ART
38www.be-on-quality.com
DEVICE DESCRIPTION AND SPECIFICATION,
INCLUDING VARIANTS AND ACCESSORIES
• Basic UDI-DI or other unambiguous reference allowing traceability
• Intended population, indications, contraindications, warnings
• Principle of operation of the device and mode of action
• Rationale for considering the product a medical device
• Device classification, applicable rule and rationale
• Explanation of any novel features
39www.be-on-quality.com
• Description of accessories
• Description of all variants of the device
• Description of the key functional elements
• Description of all the relevant raw materials
• Technical specifications, dimensions and performance attributes
• Reference and overview of previous and similargenerations of the subject device and device market history
DEVICE DESCRIPTION AND SPECIFICATION,
INCLUDING VARIANTS AND ACCESSORIES
40www.be-on-quality.com
DESIGN AND MANUFACTURING INFORMATION
• Information about the design stages
• Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, thecontinuous monitoring and the final product testing
• Identification of all sites including suppliers and subcontractors; where design and manufacturing activities are performed
41www.be-on-quality.com
Polymerization
Injection molding…
Material processing
like cutting, cleaning
polishing gluing
Lubricants, coating,
glue, cleaning agents
labels (glue, dye,
solvents)
Sterilization, process
condition
Temperature,
humidity, UV light,
aging
Additives like fillers,
reinforcement
composites, UV
Blocker, flame
retardents,
pigments and dyes,
stabilizers
Configuration
Raw materials
Historical data
Manufacturing
Packaging
Literature
42www.be-on-quality.com
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
The documentation shall contain information forthe demonstration of conformity with thegeneral safety and performance requirementsset out in Annex I that are applicable to the devicetaking into account its intended purpose, and shallinclude a justification, validation and verification ofthe solutions adopted to meet those requirements.
→Checklist in tabular form!
43www.be-on-quality.com
Risk
• Lifecycle risk
management
Benefit
• Challenge clinical
data
• User acceptance
AUDIT PITFALL:
RISK BENEFIT WITHOUT CER
44www.be-on-quality.com
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
The documentation shall contain information on:
• The benefit-risk analysis
• The solutions adopted and the results of the risk management
45www.be-on-quality.com
PRODUCT VERIFICATION AND VALIDATION
• The documentation shall contain the results of all verifications and validation tests and/or studies undertaken to demonstrate conformity with the requirements of the MDR.
6.1 Pre-clinical and clinical data
• results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications
46www.be-on-quality.com
MDR ANNEX I GSPR
Risk Management
Clinical Evaluation Biological Evaluation
Risk Analysis
Risk Management Report
Other Processes
INPUT
OUTPUT
47www.be-on-quality.com
CURRENT
• REAL STANDARD
HARMONIZATION
• EXISTING
DOCUMENTS
AUDIT PITFALL:
GAP TO CURRENT STANDARD NOT EVALUATED
48www.be-on-quality.com
PRODUCT VERIFICATION AND VALIDATION
Detailed discussion of test design, test protocols and reports with data analysis and conclusions in particular for the following:
• biocompatibility
• physical, chemical and microbiological characterization
• electrical safety and electromagnetic compatibility
• software verification and validation
• stability, including shelf life
• performance and safety
49www.be-on-quality.com
PRODUCT VERIFICATION AND VALIDATION
• the clinical evaluation report
• the clinical evaluation plan
• the PMCF plan
• PMCF evaluation report
50www.be-on-quality.com
clinical evaluation plan
clinical evaluation
report
PMCF plan
PMCF evaluation
report
FINDING PITFALL:
PMCF NOT DETAILED
FINDING PITFALL:
DECLARATION OF INTEREST (CER)
FINDING PITFALL:
MISSING INDICATIONS
51www.be-on-quality.com
PRODUCT VERIFICATION AND VALIDATION
Additional information for specific cases:
• Medicinal substances
• Requirements for devices utilizing tissues or cells of human or animal origin or their derivatives
• Devices composed of substances or combinations thereof intended to be introduced into the human body that are absorbed by or locally dispersed
• ‘CMR’ and endocrine-disrupting substances
• Sterility and microbiological condition
• Measuring Function
• Devices connected to other devices
52www.be-on-quality.com
Type Testing
Type Tests
Collaterals
Homecare
EmergencyAlarm
ElectricalSafety
Biological Safety
Cytotox
Chemical Character
SensitationIrritation
Sterility
Usability
Productrelevant
standards
80601-2-x
60601-2-xISO14xxx
Costs: 20k€
Costs: each
8k€
Costs: each
5k€
Costs: 5k€Costs: 20k€ - 100k€
53www.be-on-quality.com
New Approach
Collecting
data sheets is
not sufficient