Technical Documentation Helga Seiler M.Sc. Vision Science and Business (Optometry) Manager RA
Disclaimer 2 The following list of information is not exhaustive The information and views given in the following presentation are those of the author and do not necessarily reflect the official opinion of a company and organisation
Technical Documentation 3 How to start? Where do you find good information?
Sources for information 4 http://eur-lex.europa.eu/legalcontent/en/txt/?uri=consil:pe_14_2017_init e.g. new MDR http://ec.europa.eu/growth/sectors/medicaldevices/guidance_de MEDDEV-Documents http://ec.europa.eu/growth/tools-databases/nando/ Informations about Notified Bodies
Sources for information 5 http://www.team-nb.org NB-Med Documents List of designating authorities Websites of the designating authorities of each member state Websites of companies dealing with QM e.g. http://meddev.info https://www.emergogroup.com
Sources for information for TD 6 93/42 EEC MDD NB-Med 2.5/1 Rec. 5 rev. 4 (03/2010) Meddev 2.7/1 Rev. 4 (06/2016) MDR (after its publication): Ch. VII Sec 1 Art 83, Art 84, Art 86 Ann II Technical Documentation Ann III Technical Documentation on PMS
Sources for information - Standards 7 DIN EN ISO 14971: 2013 Risk managment ISO14155: 2011 Clinical investigation of medical devices for human subjects - Good clinical practice EN ISO 11980: 2012 Ophthalmic optics - Contact lenses and contact lens care products Guidance for Clinical Investigations and all standards necessary for manufacturing process, labelling, etc.
TD acc. to MDR Ann II, III - table of contence (minimum) 8 1. Device description & specification, including variants & accessories 2. Information to be supplied by manufacturer 3. Design and manufacturing information 4. General safety & performance requirements 5. Benefit-risk analysis and risk management 6. Product verifcation and validation 7. Post market surveillance plan
4. General safety & performance requirements 9 Acc. to MDR Ann I increased number and level of detail now checklist with about 220 items to review Precise identity of controlled documents: harmonised standards, Common Specifications or other methods (with cross-reference) ISO 14534: 2011 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
5. Benefit-risk analysis and risk management 10 Ann 1 Sec 3: Continuous iterative process throughout the entire lifecycle DIN EN ISO 14971: 2013 Risk management Information from post-market surveillance should be incorporated
6. Product verification and validation 11 Pre-Clinical and clincal data Results & analysis of all verification and validation tests to demonstrate conformity Detailed information: e.g. design, test & study protocols, biocompatibility Clinical evaluation report & updates Art 61 & Ann XIV Part B PMCF plan Ann XIV Part
6. Product verification and validation - biocompatibility 12 ISO 10993-1to 20 & ISO 9394 EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system: Framework for all more specific standards Material, Performance, features and physical characteristics of final product Assessment of final product EN ISO 9394:2012 Ophthalmic optics - contact lenses and contact lens care products
6. Prod. verification & validation - Clinical Evaluation: Art 61 13 Clinical evaluation Art 61 and Ann XIV Part A Manufacturer shall specifiy level of clinical evidence necessary to demonstrate safety and performance Class IIb and III: Consultation of expert panel necessary prior to clinical evaluation
6. Prod. verification & validation - Clinical Evaluation: Art 61 14 Critical evaluation of relevant scientific literature (safety, performance, design, intended purpose) Critical evaluation of results of all available clinical investigations consideration of alternative current available treatment options
6. Prod. verification & validation - Clinical Evaluation: Art 61 15 Exceptions only for implantable and class III devices: Certain conditions for modifications of already marketed devices Devices lawfully placed on market in acc. with 93/42 EEC Sufficient clinical data And in compliance with product relevant CS for the clinical evaluation of that kind of device
7. Post-market surveillance plan 16 Art 83-86 & Ann III Art 83 PMS system of manufacturer Proportionate to risk class Actively & systematically gathering data Recording and analysing data on quality, performance and safety Throughout lifetime => Update benefit-risk determination, design, IFU, labelling, clinical evaluation, FSCA
7. Post-market surveillance plan 17 Ann III => Plan acc. to Art 83 & 84 shall address: Information concerning serious incidents, including PSUR and FSCA Records referring to non-serious incidents & sideeffects Trend-reporting Literature, feedbacks, complaints,...
7. Post-market surveillance plan 19 Art 86 Periodic safety update report (PSUR) for class IIa, IIb and class III For each category or group throughout lifetime Results & analysis of the PMS data => conclusions for benefit-risk determination => main findings of the PMCF => volume of sales, other characteristics of population using the device Class IIb & III: at least annually Class IIa: at least every 2 years / when necessary
Technical Documentation summary 20 Technical Documentation will have to be more detailed Will need more focus on Clinical Evaluation Post market surveillance Risk management
21 Thank you! Helga Seiler M.Sc. Vision Science and Business (Optometry) Manager RA seiler.qm@gmail.com