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Slide 1 Classification of Medical Devices – Clinical Evaluation and Conformity Assessment Dr. Juliet M. Doran Pre-market Evaluation Assessor Human Products.

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Presentation on theme: "Slide 1 Classification of Medical Devices – Clinical Evaluation and Conformity Assessment Dr. Juliet M. Doran Pre-market Evaluation Assessor Human Products."— Presentation transcript:

1 Slide 1 Classification of Medical Devices – Clinical Evaluation and Conformity Assessment Dr. Juliet M. Doran Pre-market Evaluation Assessor Human Products Authorisation & Registration Committee for Advance Therapies (CAT) Presidency meeting 28 th February 2013

2 Slide 2 Presentation Content Definition of a Device Scope of MD legislation Medical device life-cycle Classification Clinical Evaluation Conformity Assessment

3 Slide 3 Medical Device Legislation Definition of a Medical Device (Article 1 93/42/EEC) medical device any instrument, apparatus, appliance, software, material or other article… intended …for… diagnosis, prevention, monitoring, treatment or alleviation of disease…or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

4 Slide 4 Medical 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 body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

5 Slide 5 in vitro diagnostic medical device …any medical device which is a reagent… instrument, or system… intended …to be used in vitro for the examination of specimens, …for the purpose of providing information: concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. Medical Device Legislation- Definition of an In-Vitro Diagnostic Device (Article 1 98/79/EC

6 Scope of MD legislation (Directive 93/42/EC) Does not apply to… IVDs, active implantable medical device MPs covered by 2001/83/EC Cosmetic products Human blood, blood products, plasma or blood cells of human origin Transplants or tissues or cells of human origin Viable transplants or tissues or cells of animal origin.

7 Scope of MD legislation Does apply to devices incorporating… a medicinal product, with an ancillary action a medicinal product derived from human blood or plasma, with an ancillary action non-viable tissues of animal origin

8 Lifecycle of Medical Device 3. Registration with Competent Authority Class I & Custom-made devices Class IIa, Class IIb, Class III & Class I sterile or measuring 4. CE-marking 5. Post Market Surveillance 5. Post-market Clinical Follow-up Prototype 1. Classification 3. Conformity Assessment by Notified Body 2. Clinical Evaluation 4. CE marking & certificate issued XXXX Post-market Pre-market

9 1. Classification To 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 devices Rules 5-8- Invasive devices Rules Active devices Rules Special rules These consider: Duration contact (e.g. 1second 15years?) 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. ClassRiskExamples ILow Wheelchairs, simple wound dressings, Stethoscopes, ECG electrodes, syringes IIaMedium Contact lenses, ECG machines, electronic BP monitors IIb Medium – High Peripheral Bare Metal Stents (BMS), External Defibrillator IIIHigh Joint replacements, Drug-Eluting Stents (DES), Pacemakers,

10 Rule 13** Drug-Device Combinations (Class III) If MD contains MP: 1.Device aspect assessed under device legislation but general principles of other MP legislation must apply 2.Notified body must verify the usefulness of the MP 3. Drug consultation required with a Competent Authority/EMA must give opinion on thequality, 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 MD e.g. Bone cement containing antibiotic MD – Primary mode of action pharmacological, immunological / metabolic => Medicinal Product (MP) e.g. Asthma inhaler MP e.g. Patches for trans-dermal drug delivery MP 1. Classification

11 Rule 17 Devices Containing Tissues of Animal Origin (Class III) If MD contains Tissue of animal origin (relevant): 1.(In addition to MDD) Manufacturer subject to Directive 2003/32/EC (Regulation 722/2012 from 28 th August 2013). 2.If starting material has an EDQM CEP- considered by notified body in its overall assessment. 3.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) 4.SER circulated to all CAs for comments, considered by notified body.

12 1. Classification The 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). Doesnt matter if primary mode of action is physical (i.e. by a medical device)

13 2. Clinical Evaluation All medical devices require clinical evaluation: Class I, IIa, IIb, III & AIMD Must be based on clinical data- 3 different routes: Clinical investigation Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data for (high risk devices): »Implantable devices »Class III devices »Active implantable medical devices. 1. Scientific literature route2. Clinical Investigation route 3. Combination route Critical evaluation of the relevant scientific literature demonstration of equivalence between devices data adequately demonstrate compliance with Essential Requirements Critical evaluation of the results of clinical investigation(s) Combination of Scientific literature route + Clinical Investigation route

14 3. 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 ( Medical DevicesClass I with a measuring or sterile function Class IIa, Class IIb & Class III Active Implantable Medical Device All

15 3. 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 NBs MD Non-active functional implants39 MD Non-active soft tissue implants38 MD Devices for wound care48 MDS Medical devices incorporating medicinal substances, according to Directive 2001/83/EC 37 MDS Medical devices utilising tissues of animal origin, according to Directive 2003/32/EC 26 MDS 7003-Medical devices incorporating derivatives of human blood, according to Directive 2000/70/EC, amended 16 MDS 7008-Medical devices utilising nano-materials22

16 Class III devices (assessed by a notified body under e.g. Annex II) would require… ANNEX I Essential Requirements review of device including… General Risk : benefit assessment (clinical & safety) and reduction (Risk EN ISO 14971) State-of-the-art design & construction Lifetime device performance Transport& storage impact Clinical evaluation (Clinical Investigation EN ISO 14155) Side effects Residual risk information Chemical, physical & biological properties Materials of construction: toxicity, flammability Compatibility of materials of construction Biocompatibility (EN ISO 10993) & Compatibility with other contact materials Device MP compatibility Pre-clinical testing- animal, bench, computer Drug & blood consultation Residual material contamination, leaking & ingress 3. Conformity Assessment (by a Notified Body)

17 Infection & microbial contamination Animal tissues- SER/EDQM (TSE EN ISO ) Sterility & packaging validation and stability (Sterilisation EN ISO 11135, 556) Construction & environmental properties Combination safety & performance testing Device ergonomics, usability & interference (Usability EN ISO 62366) Measurement Accuracy & stability (Thermometers ISO EN 1060) Radiation Energy sources (Medical electrical equipment EN 60601) Labelling/IFU (Labelling EN ISO 980, IFU EN ISO1041) Full Quality System (ISO13485) plus… Clinical data SOPs Design Control & Verification SOPs Post-market surveillance system In-process and Final QC release tests & SOPs Sterilisation, Purchasing, labelling SOPS 3. Conformity Assessment (by a Notified Body)

18 Design dossier review of device Product description & Intended use Design Verification & Validation Risk assessment Standards applied Sterilisation, Biocompatibility, Risk etc. Solution to Essential Requirements Pre-Clinical Testing Bench Testing / simulation Animal Model Clinical Evaluation Literature review Clinical Investigation (Human Model) First In Man Acute In-Vivo Device Performance Device labelling & IFU Stability Testing Significant changes Performance / Complaint Analysis 3. Conformity Assessment (by a Notified Body)

19 Declaration of Conformity by the manufacturer CE certificate issued Notified body assessment of all Substantial Changes Annual surveillance, recertification- 3-5 years. 3. Conformity Assessment (by a Notified Body)


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