Presentation on theme: "Classification of Medical Devices –"— Presentation transcript:
1Classification of Medical Devices – Clinical Evaluation and Conformity AssessmentCommittee for Advance Therapies (CAT) Presidency meetingDr. Juliet M. DoranPre-market Evaluation AssessorHuman Products Authorisation & Registration28th February 2013
2Presentation Content Definition of a Device Scope of MD legislation Medical device life-cycleClassificationClinical EvaluationConformity Assessment
3Medical Device Legislation Definition of a Medical Device (Article 1 93/42/EEC) any instrument, apparatus, appliance, software, material or other article…intended …for…— diagnosis, prevention, monitoring, treatment oralleviation of disease…or handicap,— investigation, replacement or modification ofthe anatomy or of a physiological process,— control of conception,and which does not achieve its principal intended action in or onthe human body by pharmacological, immunological or metabolicmeans, but which may be assisted in its function by such means;”
4Medical Device Legislation- Definition of an Active Implantable Device (Article 1 90/385/EEC) ‘‘active implantable medical device’ …any device …intended to be totally or partially introduced, surgically or medically, into the human bodyor by medical intervention into a natural orifice, and which isintended to remain after the procedure;”
5Medical Device Legislation- Definition of an In-Vitro Diagnostic Device (Article 1 98/79/EC “‘in vitro diagnostic medical device’…any medical device which is a reagent… instrument,or system… intended …to beused in vitro for the examination of specimens,…for the purpose of providing information:— concerning a physiological or pathological state,or— concerning a congenital abnormality, orto determine the safety and compatibility withpotential recipients, or— to monitor therapeutic measures.”
6Scope of MD legislation (Directive 93/42/EC) Does not apply to…IVDs, active implantable medical deviceMPs covered by 2001/83/ECCosmetic productsHuman blood, blood products, plasma or blood cells of human originTransplants or tissues or cells of human originViable transplants or tissues or cells of animal origin.
7Scope of MD legislation Does apply to devices incorporating…a medicinal product, with an ancillary actiona medicinal product derived from human blood or plasma, with an ancillary actionnon-viable tissues of animal origin
8Lifecycle of Medical Device Prototype1. Classification3. Conformity Assessmentby Notified Body2. Clinical Evaluation4. CE marking &certificate issuedXXXXPre-marketClass I& Custom-made devicesClass IIa, Class IIb, Class III & Class I sterile or measuring3. Registrationwith Competent Authority4. CE-marking5. Post Market SurveillancePost-market5. Post-market Clinical Follow-up
91. ClassificationTo qualify as a medical device- must have medical purpose & primary physical mode of action.4 device classes, based on risk:Device class determined by 18 rules:Rules 1-4- Non invasive devicesRules 5-8- Invasive devicesRules Active devicesRules Special rulesThese consider:Duration contact (e.g. 1second15years?)Degree invasiveness (e.g. intact surgery?)Anatomy affected (e.g. oral cavity CNS?)Active (i.e. uses a power source)Re-usable?Device Class determines the route to CE marking.ClassRiskExamplesILowWheelchairs, simple wound dressings, Stethoscopes, ECG electrodes, syringesIIaMediumContact lenses, ECG machines, electronic BP monitorsIIbMedium – HighPeripheral Bare Metal Stents (BMS), External DefibrillatorIIIHighJoint replacements, Drug-Eluting Stents (DES), Pacemakers,
101. Classification Rule 13** Drug-Device Combinations (Class III) If MD contains MP:Device aspect assessed under device legislation but general principles of other MP legislation must applyNotified body must verify the ‘usefulness’ of the MP‘Drug consultation’ required with a Competent Authority/EMA must give opinion on the ‘quality, safety and benefit/risk profile’.**Rule 13 also covers human blood derivatives.Primary mode of action physical=> Medical Device (MD)e.g. Drug-Eluting Stent → MDe.g. Bone cement containing antibiotic → MDPrimary mode of action pharmacological, immunological / metabolic => Medicinal Product (MP)e.g. Asthma inhaler → MPe.g. Patches for trans-dermal drug delivery → MP
111. ClassificationRule 17 Devices Containing Tissues of Animal Origin (Class III)If MD contains Tissue of animal origin (relevant):(In addition to MDD) Manufacturer subject to Directive 2003/32/EC (Regulation 722/2012 from 28th August 2013).If starting material has an EDQM CEP- considered by notified body in its overall assessment.If starting material has no EDQM CEP, the notified body prepares a Summary Evaluation Report (SER) (conduct risk assessment, review alternative materials, evaluate source of tissue)SER circulated to all CAs for comments, considered by notified body.
121. ClassificationThe exception to the 18 medical device classification rules is….‘Medical devices’ containing Advanced Therapy Medicinal Products (ATMPs)- combined ATMPs under ATMP Regulation No 1394/2007).Doesn’t matter if primary mode of action is physical (i.e. by a medical device)
131. Scientific literature route 2. Clinical Investigation route 2. Clinical EvaluationAll medical devices require clinical evaluation: Class I, IIa, IIb, III & AIMDMust be based on clinical data- 3 different routes:Clinical investigationClinical investigations “shall be performed unless it is duly justified” to rely on existing clinical data for (high risk devices):Implantable devicesClass III devicesActive implantable medical devices.1. Scientific literature route2. Clinical Investigation route3. Combination routeCritical evaluation of the relevant scientific literaturedemonstration of equivalence between devicesdata adequately demonstrate compliance with Essential RequirementsCritical evaluation of the results of clinical investigation(s)Combination ofScientific literature route+Clinical Investigation route
143. Conformity Assessment (by a Notified Body) Notified bodies assess medium and high risk devices for conformity:Notified bodies are-Designated by their national Designating Authority as competent for particular device types &Notified to the European Commission as NANDO scope expressions.Monitored routinely by Designating Authority.Currently 77 notified bodies for medical devices in Europe (http://ec.europa.eu/enterprise/newapproach/nando/).Medical DevicesClass I with a measuring or sterile function Class IIa, Class IIb & Class IIIActive Implantable Medical DeviceAll
153. Conformity Assessment (by a Notified Body) The number of (the 77) notified bodies designated to assess selected device types/technologies:(Ref.Medical Device Scope ExpressionNo. of NBsMD Non-active functional implants39MD Non-active soft tissue implants38MD Devices for wound care48MDS Medical devices incorporating medicinal substances, according to Directive 2001/83/EC37MDS Medical devices utilising tissues of animal origin, according to Directive 2003/32/EC26MDS 7003-Medical devices incorporating derivatives of human blood, according to Directive 2000/70/EC, amended16MDS 7008-Medical devices utilising nano-materials22
163. Conformity Assessment (by a Notified Body) Class III devices (assessed by a notified body under e.g. Annex II) would require…ANNEX I Essential Requirements review of device including…GeneralRisk : benefit assessment (clinical & safety) and reduction (Risk EN ISO 14971)State-of-the-art design & constructionLifetime device performanceTransport& storage impactClinical evaluation (Clinical Investigation EN ISO 14155)Side effectsResidual risk informationChemical, physical & biological propertiesMaterials of construction: toxicity, flammabilityCompatibility of materials of constructionBiocompatibility (EN ISO 10993) & Compatibility with other contact materialsDevice <-> MP compatibilityPre-clinical testing- animal, bench, computerDrug & blood consultationResidual material contamination, leaking & ingress
173. Conformity Assessment (by a Notified Body) Infection & microbial contaminationAnimal tissues- SER/EDQM (TSE EN ISO )Sterility & packaging validation and stability (Sterilisation EN ISO 11135, 556)Construction & environmental propertiesCombination safety & performance testingDevice ergonomics, usability & interference (Usability EN ISO 62366)MeasurementAccuracy & stability (Thermometers ISO EN 1060)RadiationEnergy sources (Medical electrical equipment EN 60601)Labelling/IFU (Labelling EN ISO 980, IFU EN ISO1041)Full Quality System (ISO13485) plus…Clinical data SOPsDesign Control & Verification SOPsPost-market surveillance systemIn-process and Final QC release tests & SOPsSterilisation, Purchasing, labelling SOPS
193. Conformity Assessment (by a Notified Body) Declaration of Conformity by the manufacturerCE certificate issuedNotified body assessment of all Substantial ChangesAnnual surveillance, recertification- 3-5 years.