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
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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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Slide 1
Classification of Medical Devices –Clinical Evaluation and Conformity Assessment
Dr. Juliet M. DoranPre-market Evaluation AssessorHuman Products Authorisation & Registration
Committee for Advance Therapies (CAT) Presidency meeting
28th February 2013
Slide 2
Presentation Content
• Definition of a Device
• Scope of MD legislation
• Medical device life-cycle
• Classification
• Clinical Evaluation
• Conformity Assessment
Slide 3
Medical Device LegislationDefinition 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;”
If MD contains MP:1. Device aspect assessed under device legislation but general principles of other
MP legislation must apply2. Notified body must verify the ‘usefulness’ of the MP3. ‘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)
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 28th 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.
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).
•Doesn’t matter if primary mode of action is physical (i.e. by a medical device)
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 route 2. 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 ofScientific literature route
+Clinical Investigation
route
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 (http://ec.europa.eu/enterprise/newapproach/nando/).
0050 0123 0086 0124
Medical Devices Class I with a measuring or sterile function Class IIa, Class IIb & Class III
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 information
Chemical, physical & biological propertiesMaterials of construction: toxicity, flammability Compatibility 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
3. Conformity Assessment (by a Notified Body)
Infection & microbial contaminationAnimal tissues- SER/EDQM (TSE EN ISO 22442 )Sterility & packaging validation and stability (Sterilisation EN ISO 11135, 556)
Construction & environmental properties Combination safety & performance testingDevice ergonomics, usability & interference (Usability EN ISO 62366)
Measurement Accuracy & 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 SOPs Design Control & Verification SOPs Post-market surveillance systemIn-process and Final QC release tests & SOPs Sterilisation, Purchasing, labelling SOPS
3. Conformity Assessment (by a Notified Body)
Design dossier review of deviceProduct description & Intended use Design Verification & ValidationRisk assessmentStandards applied
Sterilisation, Biocompatibility, Risk etc. Solution to Essential RequirementsPre-Clinical Testing
Bench Testing / simulationAnimal Model
Clinical Evaluation Literature reviewClinical Investigation (Human Model)
Declaration of Conformity by the manufacturerCE certificate issuedNotified body assessment of all Substantial ChangesAnnual surveillance, recertification- 3-5 years.