MDR AND THE APPLICATION PROCESS Initial steps to certification
01 GENERAL INFORMATION Intertek Medical Notified Body and the MDR Transition
INTERTEK MEDICAL NOTIFIED BODY LOCATIONS IMNB AB HQ Sweden IMNB Finland North China and America South East Asia IMNB UK India MDR and the application process 3
IMNB SCOPE OF DESIGNATION MDA MDN MDS MDT MDS 1001 Devices incorporating medicinal substances (Article MDA 0201-MDA 0204 117 devices only) Active non-implantable MDS 1004 Devices which are MDN 1101 – MDN 1104 devices for imaging, also machinery Non-active implants and MDS 1005 Devices in sterile monitoring and / or long term surgically invasive condition diagnosis All except of MDT 2013 devices MDS 1006 Reusable surgical MDA 0301 – MDA 03018 Devices which have MDN 1201 – MDN 1214 instruments Active non-implantable MDS 1008 Devices utilizing Non-active non-implantable undergone reprocessing therapeutic devices and biologically active coatings… devices (except MDN 1206, general active non- MDS 1009 Devices incorporating 1207, 1212, 1214) implantable devices (except software… MDS 1010 Devices with MDA 0304, 0309, 0310, measuring function 0314, 0317) MDS 1011 Devices in system and procedure packs MDR and the application process 4
MDR TRANSITION A BRIEF REMINDER 2017 2018 2019 2020 2021 2022 2023 2024 2025 27th May 2022 27th May 2025 MDD certificates issued prior 25th Prohibited to make MDD devices May 2017 become void. available on the market. Insert copy Insert copy Insert copy 3 MDR 1 2 4 Insert copy Insert copy 26th May 2020 27th May 2024 MDR applies All MDD certificates have expired. No MDD certificates will be issued. MDR and the application process 5
02 MDR APPLICATION PROCESS How to apply and what to consider?
MDR APPLICATION PROCESS AN OVERVIEW 01 04 03 02 Proposal Conformity Pre- Formal and Assessment Application Application Agreement Activities MDR and the application process 7
1. PRE-APPLICATION Pre- Application Use of pre-application form via INTERTEK MEDICAL NOTIFIED BODY webpage • Preliminary verification that • Device(s) are covered by MDR Formal • Classification in acc. to MDR Application • Device(s) fall within MDR designation of IMNB • Provision of budget estimate for potential client • Choice to request a formal application package Proposal Important considerations for manufacturer: and Agreement • Are my devices medical devices or devices w/o medical purpose in acc. to MDR? → MDR Article 2(1) and Annex XVI • What classification do my devices have? → MDR Annex VIII • What codes are applicable for my corresponding types of devices → EU Regulation 2017/2185 Conformity Assessment • Is my Notified Body of choice designated for my devices? → NANDO Activities MDR and the application process 8
2. FORMAL APPLICATION Pre- Application Complete Client Information Form (CIF) and Device List • Final verification of • Manufacturer’s Information (Legal manufacturer, Authorized representative, Distributor, etc.) • Management System Information (Scope of certification, Sites, Processes, Formal Suppliers, etc.) Application • Medical Device Information (Basic UDI-DI, Class, MDA/MDN, MDS, MDT, EMDN , etc.) • Capacity and Coverage by IMNB (Designated for devices, Sufficient competencies, etc) Proposal Important considerations for manufacturer prior to formal application: and Agreement • What is my role and what are my obligations in acc. to MDR? • How is my organisation and my QMS structured, organised, managed? • Have I assigned UDIs to the devices? • How are my devices classified and categorised? Conformity • Have I made myself familiar with the new coding systems (MDA/MDN, Assessment MDS, MDT, EMDN)? Activities • Is my QMS and are my Technical Documentations in full compliance with 9 MDR requirements?
3. PROPOSAL AND AGREEMENT Pre- Application Specifies: • Scope of certification • Audit criteria Formal Application • Number of TD assessments prior certification • Audit days prior certification and surveillance • Rights and obligations of manufacturer and Proposal and Notified Body Agreement → The proposal will automatically turn into an agreement as soon as the manufacturer and IMNB have signed it. Conformity Assessment Activities MDR and the application process 10
4. CONFORMITY ASSESSMENT ACTIVITIES Pre- Application PRIOR INITIAL CERTIFICATION • Technical Documentation Assessment • Number of assessment depends on number of categories of devices (IIa), generic device groups (IIb), devices (IIb implants and III) Formal Application • Sampling of at least one (1) device per category, device group • Initial certification audit • Number of audits depending of number of sites Audit performance after 1 st round of all initial TD assessments performed • SURVEILLANCE Proposal and • Technical Documentation Assessment Agreement • Number of assessments depends on number of devices in each category, generic device group • Sampling has to cover entire range of products during validity period of certificate • Conformity If only few devices and these have been assessed further sampling will focus on Assessment PMS during audits Activities • Surveillance audits 11 • Annual surveillance (at least 4 surveillance audits prior re-certification)
03 SURVEILLANCE AND CHANGES UNDER MDD Activities during transition period?
SURVEILLANCE UNDER MDD LATEST UNTIL 26 TH MAY 2024 Technical Documentation Surveillance Audits (MDD) Post Market Surveillance (MDD) Assessment (MDD) Even for MDD manufacturers: Continued as normal Conformity with MDR requirements Annual surveillance (can be done related to PMS, market surveillance, Focus on PSUR. parallel to MDR audits → will add vigilance necessary Sampling still possible. time to the audit) Use of new MIR Form mandatory Use of IMDRF coding mandatory MDR and the application process 13
NOTIFICATION OF CHANGES UNDER MDD • ALL reportable changes shall still be reported to IMNB even Acceptance of changes in design, intended use, for MDD certificates certificate, etc after • If a change is not a significant change in design or intended approval by the CA purpose under MDR Article 120(3), the implementation of such a change is allowed during the transitional period. 25th May 2020 Reference: MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the No changes with impact on MDR with regard to devices covered by certificates certificate → e.g. scope according to MDD or AIMDD statement • Changes requiring update of certificate will NOT be accepted under MDD. 15th March 2020 No changes requiring additional TD assessment → e.g. addition of product groups/categories Figure: IMNB’s policy for changes under MDD MDR and the application process 14
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