MDR 2017745 PERFORMANCE EVALUATION Day MDR requirements for

MDR 2017/745 PERFORMANCE EVALUATION Day MDR requirements for BDIA presentation Date June 2019 Trainer Name Martin Penver Location SGS Version 0. 0

CLINICAL EVALUATION REQUIREMENTS New Regulation gives requirements in: n. Chapter VI Article 61 -82 – covers (WHAT are ) the total requirements for Clinical Evaluation And Clinical Investigations n. Annex XIV – (How) Clinical Evaluation And Post market Clinical Follow up n. Annex XV – (How) Clinical Investigations n. Article 61 is where we will start off as this article details the Clinical Evidence overview and over the next session looks deeper in the actual requirements found in the annexes. MDR text is Aligned to MEDDEV 2. 7. 1 rev 4 2

MDR ARTICLE 61 – LITERATURE ROUTE § Literature route = Article 61 Paragraph 3 (a) device under evaluation = Article 61 Paragraph 5 (page 56) (equivalent device with Contract) Device demonstrated to be equivalent to an already marketed device not manufactured by him, where: § the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, § and the original clinical evaluation has been performed in compliance with the requirements of this Regulation, 3

FOR CLASS IIA, IIB (NOT IMPLANTABLE), CLASS I So if I can’t do § An Investigation § I have not got Literature n What is the other option Article 61 – Paragraph 10 (page 57) 4

MDR ARTICLE 61 – CLINICAL EVALUATION n Does the MDR provide the same options? YES § § Annex 1. 1 d = Article 61 – Paragraph 10 Literature route = Article 61 Paragraph 3 (a) Clinical Investigation Route = Article 61 – Paragraph 3 (b) Literature & CI Route = Annex XIV part A Paragraph 1 (e) “analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits. ” n Important NOW Article 61 – Paragraph 6 “The requirement to perform clinical investigations shall not apply to implantable devices and class III devices: (a) which have been lawfully placed on the market or put into service in accordance with Directive 93/42/EEC and for which the clinical evaluation: — is based on sufficient clinical data” - so Grandfathering of data from MDD is acceptable – based on SGS review under MDD is adequate - so what is required ? 5

Pre CE clinical data ac re PM tive pr S o – a cti ve PM CF S PM es ur tig e at & io n Li rma te ra nce tu re Li te ra (Clients In ture device ve ) (E q st ig uiv de at vic Li i t on e) In era v t fo Pe r WEIGHT OF SUFFICIENT CLINICAL DATA – EXISTING DEVICE DATA as an existing DEVICE Post CE clinical data 6

MDR ARTICLE 61 – PARAGRAPH 10 ( NON CLINICAL TESTING WAS 1. 1. D MDD) (actual text) Meet GS&P requirements based on results of non-clinical testing methods alone, including : n performance evaluation, (Can be Post Market Surveillance PMS) n Bench testing § regarding in design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable. , n and pre clinical evaluation, to be adequate 4. 5. 4. Pre-clinical evaluation assessment (see page 134) SO under MDR you MAY have Bench & Pre-clinical evaluation data but how good is the PMS? 7

GOOD PROACTIVE PMS – DENTAL BURR n Customer Complaint analysis (per month) § § § Product design related complaints Product quality related complaints Other complaints n Complaints per 1000 sold = 0. 0071, analysis of main reasons, comparison with previous years per type of complaint. § Only negative – no breakdown of what were European sales and complaints n 15 off worldwide customer surveys in 2017 received § Analysis on improvement in scores compared to previous year. n 4 off Literature reviews included which were published in last 2 years – with a review and any action required – copy of all literature included in appendix n Review Incident reporting in USA, Australia, Canada, UK for the device over the last year. n Testing – § Sample testing of Clients device placed on the market and compared with previous results § Sample testing as a comparative study with 5 different competitors devices 8

WEIGHT OF SUFFICIENT CLINICAL DATA PM tive pr S o – a cti ve ac re S Device = Dental Burr PM Pe ev rfo alu rm at anc ion e – EXISTING DEVICE DATA as an existing DEVICE Pre CE clinical data Post CE clinical data 9

Performance evaluation, (Can be Post Market Surveillance PMS) NON CLINICAL TESTING FOR A Bench testing “lets look at this next” DENTAL IMPLANT Pre-clinical evaluation, to be adequate 4. 5. 4. Pre-clinical evaluation assessment (see page 134) 10

BENCH TESTING n Summary Report to provide an brief overview of the conducted test. n Test Reports for non clinical bench performance require an objective description of methods, pre defined pass/fail criteria, results, and a conclusion to be considered complete. § § § Test performed Objective of the test Description of test methods/procedures • • • § § Test sample information Test sample size/selection Test protocol Pre defined pass/fail criteria Test results • • • Data points Data analysis Protocol deviations § Discussion of the conclusions 11

POSSIBLE BENCH TESTING n Peel test n Adhesive test n Surface finish n Breathable test n Shear test n Absorbsion test n Tensile test n User ability n Push ability n Dexterity – instruments are they left handed ? n Torsion n Corrosion n Biocompatibility n Animal models n Shelf life testing n Cadaver testing n Device life testing (accelerated aging) n Representative model – testing n Electrical n Computer modelling n Comparable testing with competitor device n Simulated use testing n Any More ? ? ? 12

NOW CONSIDER PMS ACTIVITIES MDR DOES NOT PROVIDE EXAMPLES OF PROACTIVE AND REACTIVE PMS Technical Literature reviews – Competitor reviews Client investigations – failure analysis Registries (implants) Active device tracking Post CE clinical trials / studies Experience on equivalent devices Materiovigilance Maintenance reports Quality Control Testing Internal Product audits Other bodies (the CA) Service Returns Warranty Claims Repairs – service reports Field Service User reactions during training programs Sales / Marketing Customer surveys Sales Call Feedback Post market study Reps or Distributor Feedback Experts user groups - Conferences The Media – Social Media & Website Note: Literature reviews are only pro-active if the manufacture regularly checks for published data on their or competitors devices, and this can be demonstrated – so this answer is subjective 13

PRE CLINICAL EVALUATION 4. 5. 4 (ANNEX VII) n The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address: a) the planning, conduct, assessment, reporting and, where appropriate, updating of the pre clinical evaluation, in particular of • the scientific pre clinical literature search, and • the pre clinical testing, for example laboratory testing, simulated use testing, computer modelling, the use of animal models, b) the nature and duration of body contact and the specific associated biological risks, c) the interface with the risk management process, and d) the appraisal and analysis of the available pre clinical data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I. 14

PRE CLINICAL EVALUATION 4. 5. 4 (ANNEX VII) n assessment of pre clinical evaluation procedures and documentation shall address the results of § literature searches and all validation, verification and testing performed and conclusions drawn, and shall § typically include considering the use of alternative materials and substances and take account of the packaging, § stability, including shelf life, of the finished device. n Where no new testing has been undertaken by a manufacturer or where there are deviations from procedures, the notified body in question shall critically examine the justifi cation presented by the manufacturer. 15

Dental Implant EXERCISE – NOW CONSIDER PRE CLINICAL Bench Tests ? PMS ? Preclinical evaluation ? 1) Connectability to abutment tools Literature reviews – Competitor reviews 2) Device life Client investigations – failure analysis 3) Shear / Fracture / Hardness test PMCF Use of alternative materials 4) Biocompatibility Dentist feedback / surveys / conferences Alternative treatments (state of the art /) 5) Dimensional Returns 6) Raw Material Identification C of C QC Testing of their device against a competitors Confirm it meets EN 1642 Materiovigilance Distributor / Dentist or patient Feedback Is This Sufficient Clinical data ? NO –if NEW implant investigation - but YES for MDD 16

WEIGHT OF SUFFICIENT CLINICAL DATA PM tive pr S o – a cti ve ac re S PM Pe ev rfo alu rm at anc ion e – EXISTING DEVICE DATA as an existing DEVICE Pre CE clinical data Post CE clinical data 17

ANY QUESTIONS ? 18