EU MDR Deep Dive - MassMEDIC · All opinions expressed by Glen Emelock during and after this...

© 2018, All rights reserved. The CRO Group, Inc.

EU MDR Deep Dive: GSPRs, Technical Docs, PMS 19 JUNE 2018ASQ – RAPS – MASSMEDICWaltham Woods

Glen Emelock

Sr. Partner, The CRO Group

Lead Auditor, Technical Expert, NSAI


All opinions expressed by Glen Emelock during and after this presentation are solely his and do not reflect the opinions of ASQ, RAPS, MassMedic, NSAI, or affiliates, and may have been previously disseminated by him in other presentations, or on the Internet or via another medium. You should not treat any opinion expressed by Glen as a specific requirement for certification or approval or part of a particular regulatory strategy for such certification or approval, but only as an expression of his opinion. Glen’s opinions are based upon information he considers reliable, but neither ASQ, RAPS, MassMedic, NSAI, nor affiliates and/or subsidiaries warrant the completeness or accuracy, and it should not be relied upon as such. Emelock, ASQ, RAPS, MassMedic, NSAI, and affiliates and/or subsidiaries are not under any obligation to update or correct any information provided during this presentation. This presentation is intended to provide specific requirements and details of the European Medical Device Regulation. As such, it cannot address all requirements or details of the EU MDR, and thus, the information presented including but not limited to a sample of regulatory requirements, standards, guidances, and related information mentioned should be carefully reviewed and considered as part of a baseline towards establishing an overall, well‐balanced plan to address applicable essential requirements appropriate for your specific situation.

The Fine Print


Summary Info

Chapter 1 ‐ General

Chapter 2 – Design & Manufacture

Chapter 3 – Information Supplied w/Device

General Safety & Performance Requirements (GSPRs) (Annex I)



GSPRs (Annex I) Summary InfoStats:• AIMD (90/385/EEC) had 16 Essential Requirements• MDD (93/42/EEC) had 13 Essential Requirements• MDR (2017/745) has 23 GSPRsComparison:• MDR GSPRs similar to “ERs” in AIMD and MDD, similar sectioning• GSPRs generally flow in similar sequence but not always because of:

• Combining of AIMD with MDD requirements• Several expand into more requirements (risk, software, labeling)• Some requirements pushed into Article or Annex (Reprocessing (Art

17), Implant Cards (Art 18), Clinical Evals (Art 54, 61, Annex XIV), etc.)


GSPRs (Annex I) Summary InfoOrganisation• Three Chapters:

• General Requirements (1‐9) (MDD ER 1‐6)• Design, Manufacture (10‐22) (MDD ER 7‐12)• Information Supplied with the Device (23) (MDD ER 13)


What’s the same/similar

What’s Not

Chapter 1,2,3 Comparative Review



Annex I Chapter IWhat’s the Same:• GSPR 6‐8: normal use conditions, transport & storage, all known &

foreseeable risksWhat’s Not:• GSPR 1: additional risk/benefit & state of the art emphasis• GSPR 2‐5: additional risk management, usability as per ISO 14971, 62366• GSPR 9: risk for Annex XVI devices w/o medical purpose (cosmetic

contacts, aesthetic beauty, etc.)


Annex I Chapter IIWhat’s the Same:• GSPR 15: Measuring function (but now includes diagnostic)What’s Not:• GSPR 10: more detail on chemical, physical, biological and much more on

substances (wear debris, carcinogenic, mutagenic, toxic to reproduction (CMR), endocrine‐disrupting, phthalates

• GSPR 11: more infection and microbial contamination (needle stick) avoidance

• GSPR 12: medicinals expand to absorbed or locally dispersed• GSPR 13: biological expand to human tissues, non‐viable not human nor

animal• GSPR 14: Environment (RFI, Dx/Tx radiation, connection/compatibility

Maintenance/Calibration, Disposal


Annex I Chapter IIWhat’s the Same:• GSPR 21: Supplying Energy or SubstancesWhat’s Not:• GSPR 16: Protection from radiation adds 2013/59 Euratom ionizing• GSPR 17: Electronic Programmable – covered in “Software” Deep Dive• GSPR 18: Active now includes ‘devices connected to them’, cybersecurity• GSPR 19: Active Implants – code to identify device/mfr w/o surgery• GSPR 20: Mechanical/Thermal – fitting/refitting errors made impossible• GSPR 21: Supplying Energy/Substances• GSPR 22: Risks devices intended for use by lay‐persons


Annex I Chapter III (GSPR 23)What’s the Same:• 23.1 I and IIA not requiring IFU if can be used safely w/o vs ‘use is obvious’What’s Not:• 23.1 Human readable labels and machine readable ex RFID• 23.1 eIFU per 207/2012 + any subsequent regs• 23.2 UDI, unambiguous time limit for using/implanting safely• 23.3 sterile packaging details• 23.4 installation verification, EMC warnings, clinical performance,

medicinal human or animal substances, CMR/endocrine disruptors, use with combination/other devices,


Summary Info

Review of each Section

Technical Documentation (Annex II)Health Converge…or is it Collide?



Technical Documentation Organised into 6 sections:1. Device description and specification including variants and accessories2. Information to be supplied by the manufacturer3. Design and Manufacturing information4. GSPRs5. Benefit‐risk analysis and risk management6. Product verification and validation


Device Description & Specification


Complete set of:‐ Label or labels on device and its packaging and instructions for use in accepted languages in Member States where device is to be sold

‐ Implant Card and information to be supplied to patient with an implanted device (Art 18)

‐ Summary of Safety and Clinical Performance for implantable and Class III devices ( Art 32)

Information Supplied by Manufacturer


Design and Manufacturing Information• Information to allow the design stages applied to the device to be

understood• Complete information and specifications, including the manufacturing

processes and their validation, the adjuvants, the continuous monitoring and final product testing. Data shall be fully included in the technical documentation.

• Identification of all sites, including suppliers and sub‐contractors where design and manufacturing activities are performed.

Adjuvants: An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants may be added to a vaccine to modify the immune response by boosting it such as to give a higher amount of antibodies and a longer‐lasting protection, thus minimizing the amount of injected foreign material. Adjuvants may also be used to enhance the efficacy of a vaccine.


GSPRsThe documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:‐ GSPRs that apply & explanation why others do not‐ Method to demonstrate conformity‐ Harmonised standards, CS, or other solutions applied‐ Precise identity of controlled documents offering evidence of conformity


Benefit‐risk analysis and Risk ManagementThe documentation shall contain information on:‐ The benefit‐risk analysis referred to in Annex I Section 1 and 6‐ The solutions adopted and results of risk management referred to in Annex

I Section 3 (aligns with RMF per ISO 14971:2012)


Product Verification and ValidationThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.6.1 Preclinical and Clinical Dataa) Results of tests, such as engineering, lab, simulated use and animal 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;


Product Verification and ValidationThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.6.1 Preclinical and Clinical Datab) Detailed information regarding test design, complete test/study protocols, data analysis methods, data summaries, test conclusions regarding:‐ Biocompatibility – all materials in direct or indirect contact w/pt or user‐ Physical, chemical, microbiological characteristics‐ Electrical safety and EMC‐ Software verification and validation‐ Stability‐ Performance and Safety


Product Verification and ValidationThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.6.1 Preclinical and Clinical Datac) Clinical evaluation report and updates and the CE plan of Art 61 and An XIVd) PMCF plan, PMCF eval report of An XIV or justification why PMCF is n/a6.2 Additional info in specific casesa) Medicinal incl derived from human blood or plasmab) Human or animal tissues or cells or their derivativesc) Substances or combinations absorbed or locally dispersedd) Containing CMR/endocrine‐disrupting


Product Verification and ValidationThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.6.2 Additional info in specific casese) Manufacturing environment for sterile/defined microbiological conditionf) Accuracy of measuring functiong) Connected to other devices – conforms to GSPRs when connected


PMS Plan

PSUR / PMS Report

Technical Documentation on PMS (Annex III)Converge…or is it Collide?



The technical documentation on post‐market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.1.1 PMS Plan per Article 841.2 PSUR per Article 86 and PMS report per Article 85

Technical Documentation on PMS – Annex III


1.1 PMS Plan per Article 84 including:‐ information concerning serious incident, info from PSURs & FSCAs‐ non‐serious incidents and undesirable side‐effects‐ Trend reporting info‐ Relevant tech literature, databases, registers‐ User, distributor, importer feedback, complaints‐ Similar medical device publicly available info



1.1 PMS Plan per Article 84 including:The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;‐ Effective and appropriate methods and processes to assess the data‐ Reassess benefit‐risk analysis & RM‐ Tools to investigate complaints‐ Methods/protocols to communicate w/NBs and Cas‐ A PMCF plan or justification why PMCF is N/A



1.2 PSUR per Article 86 and PMS report per Article 85PSUR (Periodic Safety Update Report) required:a. At least Annually (Class IIB and III)b. When necessary and every 2 years (Class IIA)Including:Conclusions of benefit‐risk determinationMain findings of the PMCFSales volume, estimate of population using, and usage frequency (if practicable)



1.2 PSUR per Article 86 and PMS report per Article 85PMS report (Class I devices)Summarising the results and conclusions of the analyses of the post‐market surveillance data gathered as a result of the post‐market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.


EU MDR Deep Dive - MassMEDIC · All opinions expressed by Glen Emelock during and after this...

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