EU MDR Deep Dive: GSPRs, Technical Docs, PMS. 19 JUNE 2018 ASQ RAPS MASSMEDIC Waltham Woods

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1 EU MDR Deep Dive: GSPRs, Technical Docs, PMS 19 JUNE 2018 ASQ RAPS MASSMEDIC Waltham Woods Glen Emelock Sr. Partner, The CRO Group Lead Auditor, Technical Expert, NSAI

2 The Fine Print 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.

3 General Safety & Performance Requirements (GSPRs) (Annex I) Summary Info Chapter 1 General Chapter 2 Design & Manufacture Chapter 3 Information Supplied w/device 2017, All rights reserved. The CRO Group, Inc.

4 GSPRs (Annex I) Summary Info Stats: AIMD (90/385/EEC) had 16 Essential Requirements MDD (93/42/EEC) had 13 Essential Requirements MDR (2017/745) has 23 GSPRs Comparison: 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.)

5 GSPRs (Annex I) Summary Info Organisation 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)

7 Annex I Chapter I What s the Same: GSPR 6 8: normal use conditions, transport & storage, all known & foreseeable risks What s Not: GSPR 1: additional risk/benefit & state of the art emphasis GSPR 2 5: additional risk management, usability as per ISO 14971, GSPR 9: risk for Annex XVI devices w/o medical purpose (cosmetic contacts, aesthetic beauty, etc.)

8 Annex I Chapter II What 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

9 Annex I Chapter II What s the Same: GSPR 21: Supplying Energy or Substances What 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

10 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/ 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,

12 Technical Documentation Organised into 6 sections: 1. Device description and specification including variants and accessories 2. Information to be supplied by the manufacturer 3. Design and Manufacturing information 4. GSPRs 5. Benefit risk analysis and risk management 6. Product verification and validation

13 Device Description & Specification

14 Information Supplied by Manufacturer 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)

15 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.

16 GSPRs The 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

17 Benefit risk analysis and Risk Management The 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)

18 Product Verification and Validation The 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 Data a) 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;

19 Product Verification and Validation The 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 Data b) 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

20 Product Verification and Validation The 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 Data c) Clinical evaluation report and updates and the CE plan of Art 61 and An XIV d) PMCF plan, PMCF eval report of An XIV or justification why PMCF is n/a 6.2 Additional info in specific cases a) Medicinal incl derived from human blood or plasma b) Human or animal tissues or cells or their derivatives c) Substances or combinations absorbed or locally dispersed d) Containing CMR/endocrine disrupting

21 Product Verification and Validation The 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 cases e) Manufacturing environment for sterile/defined microbiological condition f) Accuracy of measuring function g) Connected to other devices conforms to GSPRs when connected

23 Technical Documentation on PMS Annex III 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 PSUR per Article 86 and PMS report per Article 85

24 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

25 Technical Documentation on PMS Annex III 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

26 Technical Documentation on PMS Annex III 1.2 PSUR per Article 86 and PMS report per Article 85 PSUR (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 determination Main findings of the PMCF Sales volume, estimate of population using, and usage frequency (if practicable)

27 Technical Documentation on PMS Annex III 1.2 PSUR per Article 86 and PMS report per Article 85 PMS report (Class I devices) Summarising the results and conclusions of the analyses of the postmarket 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.