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Design Basis

for Requirements Checklist

Annex I

Define Applicable Requirements for the


Intended Purpose
Annex I General Design and Evidence Collection

MANUFACTURER’s Processes
Section 1 Safety requirements Presumption of Conformity
Class I

Define Intended Purpose of the MD


Class I “special” includes sterile,
measuring, reusable instruments
Annex I
Section 3
Risk Management
System Article 8
Conformity Through
Harmonised Standards
Class I
Conformity
Class IIa
Annex I Risk Control Cl inical eval uation Clinical Investigation
Conformity through Common
Annex II & Technical Documentation
Annex III and QMS Assessment

Article 52 Para 7
Overview of requirements under Defines Determines Section 4 Measures Articl e 61, Annex XIV Articl es 62-80, Annex XV Article 9
Specifications

Class IIb Article 8 Use of Harmonized Class I Sterile, Measuring,


the Medical Devices Regulation Article 9 Standards / CS (All Devices paragraph 3):
General Requirements
Other means of conformity Reusable surgical instruments

Class III • Critical evaluation of relevant scientific literature of equivalent Annex XV Quality Management
Annex IX
Regulation 2017/745/EU on Medical Devices devices, if data demonstrate compliance with relevant general safety Chapter I Ethical principles – paragraph 1 Annex II Controlled Documents System
Notified
No medical and performance requirements (GSPR)* or
Section 4 Demonstrating Conformity Body
purpose Production Quality
• Critical evaluation of results of all available clinical investigations Annex XI
December 2017 (particularly if conducted according the relevant MDR procedures Methods – paragraph 2 Assurance

Demonstration of Conformity
This flowchart has been prepared by MedTech Europe as a ‘high-level overview’ of the requirements Cl assification (Articl e 51, Annex VIII) • Consideration of currently available alternative treatment options Classification

of the Medical Devices Regulation. While MedTech Europe considers the information herein to be Annex I
Annex XV Documentation/application (Article 70) Article 51 Classification of Class II a

Article 52 Para 6
reliable it makes no warranty or representation as to its accuracy, completeness or correctness. Annex I Annex VIII each device
Section 6
Performance (Class III and implantable devices, paragraph 4) Chapter II Assessment of Technical
This flowchart is intended for informational purpose only and should not be construed as legal Clinical investigation shall be performed except if: Quality Management Article 52 Documentation of a
Article 10 Characteristics Annex IX
Risk Management System and 7 Application Form System Para 6 representative device
advice for any particular facts or circumstances. Para 2 • The device is a modification of a device already marketed by
Annex I Chemical, Physical & paragraph 1 Notified for each category
the same manufacturer** Technical Documentation
Section 10 Biological Properties Body Declaration of
Article 10 Clinical evaluation Update clinical evaluation • The modified device is equivalent* to the marketed device
MedTech Europe reserves the right to change or amend the flowchart or any parts thereof at any Investigator’s Brochure Conformity
Para 3 incl. PMCF Article 61 Para 11 • The clinical evaluation of the marketed device is appropriate to Notified
Annex I Infection & Microbial NO EXEMPTION? paragraph 2 Body
time without notice. No part of this document may be modified or translated in any form or by any Section 11 Contamination demonstrate conformity to the GSPR Technical Documenting conformity (Article 19 &
means without the prior written permission of MedTech Europe. Article 10 • Are sutures, staples, dental fillings, dental braces, tooth crowns, Documentation Includes all information on Annex IV)
Technical documentation Presence of medicinal substances
Para 4 Investigation plan design, evidence and
Annex I or absorbed and locally dispersed screws, wedges, plates, wires, pins, clips or connectors (paragraph 6) Annex II &
Section 12 Paragraph 3 manufacturer’s procedures;
substances Annex III
For more information please contact the regulations & industrial policy department: Article 10 PMS plan

Obligations of
Custom made devices
regulatory@medtecheurope.org Para 5 Annex I Material of Assessment of a technical
Other information Class II b
Section 13 Biological Origin documentation of a

Generic Device Groups


*Equivalence subject to limitations: Annex XIV, Section 3

Article 52 Para 4, 5
Paragraph 4
Manufacturer
Article 10 Conformity assessment, Interaction with the Summary of Quality Management representative device of
Para 6 DoC and CE marking Annex I ** Exemptions for clinical investigation with implantable and Safety & Clinical Implantable and Class III Annex IX Article 52 each generic device
Environment and System
Section 14 Class III devices are given at art. 61.5 and 61.6 Performance Summary of device Notified Para 4 group. If II b implantable
construction assessment of Tech. Doc.
Article 27 information or Body
Article 32 for each device
and 10 UDI Annex I Diagnostic or

Define Applicable Requirements For the DEVICE


Annex X & Type Examination & exceptions envisaged
Para 7 Section 15 measuring Function
Annex XI Production QMS
Availability of Technical Notified
Article 10 Annex I Protection Against Body
Documentation, Certificates Section 16 Radiation Clinical investigation report (including a summary)
Para 8
and DoC Chapter III paragraph 7 Article 54
EU Technical
Annex I Programmable Annex IX – and 55
Documentation
Article 10 Quality Management Section 17 systems Class III, Class IIb and
Assessment Scrutiny Procedure for
Para 9 System implantable
Certificate active II b – intended to
Annex I

Certificates issued by Notified Bodies


Article 10 Active devices administer medicines
Section 18
PMS, Vigilance EU Quality
Para 10,13 Annex IX –
Annex I Active implantable Management Class III
Class IIa, IIb and III, Class
Article 10 Section 19 devices System Notified
Ensure implementation of I Sterile, Measuring and

Article 52 Para 3
Certificate Annex IX Quality Management Notified Body
Para 12 corrective actions Reusable Surgical Inst. System Body
Annex I Mechanical and Assessment of Technical
or
Article 11 If outside the EU – Article 11 Define a mandate for Section 20 Thermal Risks Documentation
EU Type To Annex X & Type Examination & Notified
Para 1 designate an EC REP Para 2 authorised rep. Annex X –
Examination EUDAMED Annex XI Production QMS Body
Annex I Devices supplying Class III and IIb
Certificate
Article 10 To Section 21 energy or substances
Registration original
Para 15 equipment manufacturer EUDAMED
Annex I Devices for lay
Section 22 persons EU Production Annex XI –
Article 54
Article 10 Coverage of potential Quality Class IIb, III, Class I
and 55
Para 16 liability Annex I Information supplied Assurance Sterile, Measuring
Section 23 with the device Certificate Funct., Reausable Scrutiny Procedure for
Surgical Instrument implantable class III
Article 15 Person Responsible for
Regulatory Compliance Other legislation Class III procedure +
Drug/ Article 52 Notified
Consultation with EMA
Devices

Additional Conformity Requirements


para 9 Body

Implantable class III


REACH / CLP or medicines competent
Patient information and Annex IX – Chapter I

Custom Made
Article 18 EU Quality authority
Implant Card
Euratom Management Or
System
Article 22 Biocides Certificate Annex XI – Part A
System and procedure packs Animal/ Class III procedure +
and 29(2) Article 52 Notified
WEEE/RoHS Human para 10 with EMA or medicines
Body
Tissues competent authority
Article From Machinery Directive
Registration, SRN
29,31 EUDAMED
Substances
introduced: Class III procedure +
Summary of safety and Article 52 Notified
Article 32 absorbed or with EMA or medicines
clinical performance para 11 Body
dispersed competent authority

Registration
Importer Obligations
Obligations of
Authorised Representatives,

Registration Economic
Article 13
Verify device compliance SRN Registration: EUDAMED
Importers, Distributors, SUD reprocessors and the
Para 1,2
Article 31 Manufacturer

Operators
Annex VI
Para 1 & 2 Authorised Rep. Part A
Article 13 Add contact details to Importer
Para 3 device or packaging or
accompanying document person referred to in Article 22 (1) and 22 (3) Article 30 National
Article 13 Verify device registration, Distributor Registration Database
EUDAMED Para 2

Post-Market Surveillance
Para 4 add own details
Obligations of the Person Referred to in Article 22 (1) and 22(3)
Requirements for person referred to in Article 22 (1)

and Vigilance
Article 13 Safeguard storage and
Para 5 transport conditions Article 22 Draw up a statement in accordance with Article Add contact details, label and IFUs and
Reprocessor Obligations Para 1 Article 22 (2) 22 keep the statement referred to in
Requirements for Reprocessing of Single-

Para 5 Article 22 (2) available for the CAs Article 27

Unique Device Identification


Article 13 Keep register of complaints, Article Basic UDI-DI
Para 6 non-conforming devices, etc. Reprocessing and further use of SUD only Article 29
17 Post-Market Clinical Follow-up Basis of registration

Registration Devices
and Article 22 (3)

allowed where permitted by national law For sterilisation of systems or procedure Annex VI
Para 1 Article 22 Notified
Article 13 Inform of non-conformities and packs apply either the Annex IX or the Part Part C
Para 3 Body
use Devices (SUD)

Article Annex VI

Annex XIV, Part B


Para 7 serious risk Persons reprocessing SUD assume the A of Annex XI procedure Database Requirements
17 Post-Market Surveillance Part A

System for updating Technical Documentation on Post-Market Surveillance


obligations of manufacturer
Requirements for Importers

Article 13 Ensure implementation of Para 2 Article 95 Annex XIV, Part B


Article 22
Draw up a statement declaring
Para 3 Application of corrective actions Continuous process of Section 5 Principles of PMCF
Para 7 corrective actions Article sterilisation in accordance with the
Requirements for SUD reprocessed and Para 3 Post-Market clinical evaluation and risk Summary of Safety and
17 manufacturer’s instructions Article 83 Article 32
Inform of complaints & used within a health institution Surveillance System assessment Clinical Performance
Article 13 Para 3
Para 8 suspected incidents Annex XIV, Part B,
Section 6 and 7 PMCF Plan PMCF Plan
Article Add contact details and other relevant Article 22 Cases when the system or procedure pack
Article 13 Keep Declaration of Conformity 17 information (Section 23, Annex I) to the Para 4 shall be treated as a device in its own right
Para 9 and certificate(s) Para 8 label and if applicable to IFUs Post-Market All Update over device Update over device
Article 84
Surveillance Plan Classes lifecycle lifecycle
Article 13 Clinical

Analyse findings
Cooperation with Competent
Para 10 Authorities Evaluation Article 70
Article 53

Electronic System for Studies


Report Article 73
Identification within
Notified body
Article 25 Post-Market Class (Annex XIV Application for Clinical
involvement

Electronic System for NB Certificates


the supply chain Authorised Representative Obligations Article 85
If modify device before placing on market Surveillance Report I Part A, Investigation
Article 11 Section 4)
Article 27 Mandate Article 56
Storage of UDI data Para 2, 3, 4
Para 8
Assume the obligations of the manufacturer Notified body
EUDAMED Article 11 Periodic Safety Certificates Article 77
Verify registration of Liability Article 86 Class
Para 5 Update Report II a, II b, III PMCF
Article 30 manufacturer or Evaluation Performance Study
Within 2
Para 3 authorised representative; Termination of mandate if Article 57 Report & Summary
weeks of Article 11 Report
Authorised Representative

add own details manufacturer acts illegally: Notified


placing on Modification of Device Para 6 Notifications regarding
market communication Body
Class III and Certificates
Change of authorised Implantable EUDAMED
Article 12
Registration of the importer Market device under own representative EUDAMED
Article 31 EUDAMED Article 16 Vigilance Notified
SRN name, change intended

Placing on
Para 1 purpose or modify in a way
Body
Article 15 Person responsible for
Art 13 Para which may affect compliance Para 6
Application of corrective regulatory compliance
7/Art 95 Article 87 Reporting Serious Manuf.

the market
actions
Para 3 Para 1 Incidents Incident
Article 24 Report
Storage of UDI data
Para 8
Article 16
Para 2 Relabel or repackage device
Article 30 EUDAMED Article 87
Registration, SRN Reporting time 15 days
and 31 Para 3
Affix CE Mark
Article 95 Application of corrective (Article 20 / Annex V)
Surveillance - quality management system and devices

Para 3 actions Periodic

Reporting & Investigating Serious Incidents


Distributor Obligations Article 87 Summary
Periodic Reporting
Surveillance Assessment Para 9 Report
Article 14 Sampling
Verify device compliance
Para 2 method
Authorised Representative Mandate
- Minimum requirements Annex IX Surveillance Assessment Surveillance Trend
Article 14 Safeguard storage and Article 88 Trend Reporting
Section 3 Class IIa, IIb, III Assessment Report
Para 3 transport conditions Requirements if Relabel or Repackage a Device
Verify declaration of Report & Test
Inform of non-conformities If modify device before making available conformity, technical doc., Notified Report
Article 14
Para 4 and serious risk conformity assessment Body Analysis of Serious
Add modification activity and Article 89
Article 14 Article 16 contact details to the device, Incidents
Ensure implementation of Keep available copy of
Requirements for Distributors

Para 4 corrective actions Para 3 packaging or accompanying technical doc., declaration of


Authorised Representative - Mandate

document conformity, certificates Field Safety


Article 14 Inform of complaints & Article 87 Reporting Field Safety
Para 5 Annex IX Unannounced audit Surveillance Corrective Placing on the market and putting
suspected incidents Registration, verify device Para 81 Corrective Actions
EUDAMED Section 3.4 Class IIa, IIb and III Assessment Action into service
Article 16 Notified and UDI registration
Article 14 Keep register of complaints,
Para 3
Quality Management System Report & Test
Body
Para 5 non-conforming devices, etc. Notified Report
Device information to Article 89
competent authority Body Issue Field Safety Notice Field Safety
Article 14 Cooperation with At least 28 Article 11 Para 8
Article 16 days before upon request Notice
Para 6 Competent Authorities Inform manufacturer and Para 3
Para 4 competent authority market
Identification within device Samples and access
Article 25 to device Assessment of Corrective
the supply chain Article 89
Actions
National Preventive
Article 30
Distributor Registration Database or corrective actions
Para 2
Article 95 Application of corrective
Article 27 Inform of complaints and Para 3 actions
Storage of UDI data suspected incidents
Para 8
Terminate mandate if
Article 95 Application of corrective manufacturer acts illegally
Para 3 actions

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