Regulatory Framework for Medical Device - Ministère des...
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Regulatory Framework for Medical Device Regulatory Framework for Regulatory Framework for Medical Device Medical Device Peter Bischoff-Everding European Commission International Seminar „Safety of Health Products“ French Ministry of Labour, Employment and Health Paris, 26 May 2011
Transcript of Regulatory Framework for Medical Device - Ministère des...
Regulatory Framework for
Medical Device
Regulatory Framework for Regulatory Framework for
Medical DeviceMedical Device
Peter Bischoff-EverdingEuropean Commission
International Seminar „Safety of Health Products“
French Ministry of Labour, Employment and HealthParis, 26 May 2011
EU regulatory framework
Directive 90/385/EEC on active implantable medical devices (AIMDD)
Directive 93/42/EEC on medical devices (MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)
+ Amending and implementing measures
Safety of patients and users
Internal market
Innovativeness and competitiveness
Adapted to the specificities of the sector
Interface MD-Pharma (drug-device combination products, personalised medicine)
EU regulatory frameworkEU regulatory framework
Basic principles of device regulation
Medical device
Diagnosis, prevention, monitoring, treatment or alleviation of a disease, injury or disability, or
Investigation, replacement or modification of the anatomy or physiological process, or
Control of conception
and
Principal mode of action notpharmacological, immunological or metabolic
Basic principles of device regulation
Classification according to risk (class I, IIa, IIb, III)
Invasive (transient, short-time, long-term)
Implantable
Active / non-active
Specific hazards (e.g. contact with CNS, animal tissues, absorbable material, ionizing radiation, MD with ancillary pharmaceutical substance)
Basic principles of device regulation
Essential Requirements
Safety and performance
Design & construction „state of the art“
Chemical, physical, biological hazards
Infection and microbial contamination
Interaction, interference with other equipment
Dependence on energy source and software
Accuracy, stability, specificity of measurement and diagnostic instruments
Basic principles of device regulation
Risk/benefit analysis
Acceptable risks when weighted against benefits to the patient
Compatible with high level of protection of health and safety
Risk reduction
Elimination or reduction as far as possible (safe design and construction)
Protection measures
Information about residual risks
Basic principles of device regulation
Clinical evaluation
Required for all medical devices Critical analysis of clinical dataDemonstration of conformity with Essential Requirements
Scientific literatureClinical investigations (GCP)
Required for implantable and class III MDSubject to national notification/approval
Basic principles of device regulation
Quality management system (QMS)
Consistent compliance with regulatory requirements
(Voluntary) harmonized standards
Presumption of conformity with Essential RequirementsISO, IEC, CEN, CENELEC
Basic principles of device regulation
Conformity assessment procedure
Self-certification (only low-risk MD)
Third-party certification (for class IIa, IIb, III)
Notified Bodies
Designated and monitored by competent authorities
Assessment of QMS and design dossier (class III) or technical file (class IIa, IIb: sampling)
Prior assessment of changes to QMS or MD design
Periodic surveillance inspections of manufacturer
Certificates with limited validity / renewal
Basic principles of device regulation
Labelling
LabelInstructions for useCE-marking
Registration and Listing
Manufacturers / authorised representativesMD of class I
Basic principles of device regulation
Post-market safety
Obligations of manufacturers
Post-market surveillance plan, incl. post-market clinical follow-upReporting of serious incidents to CAApplication of Field Safety Corrective Actions (FSCA) Communication of FSCA to users by means of Field Safety Notice (FSN)
Basic principles of device regulation
Post-market safety
Responsibilities of competent authorities
Central recording and evaluation of reported incidents and FSCAInformation sharing between competent authorities (NCAR system)
Market surveillance
Measures against non-compliant MDMeasures against dangerous products
Flexibility
Timeliness
Cost-effectiveness
Supportive for innovation
Balance between pre- and post-market control
Manageable for SMEs
StrengthsStrengths
Oversight of Notified Bodies
Designation and monitoring
Uniform standards of conformity assessments
Areas for improvement Areas for improvement
Clinical investigations
Introduction of the concept „sponsor“
Coordination of technical assessment for multi-national CI
Areas for improvementAreas for improvement
Post-market safety
Consistent and timely reactions to safety issues
Coordination of analysis of serious incidents and market surveillance activities
Areas for improvementAreas for improvement
Transparency
Economic operators and medical devices
Summary device information
Traceability of devices
Internet sales
Areas for improvementAreas for improvement
Management
Medical Device Committee (experts designated by Member States)
Mechanism for harmonised interpretation and implementation
Intersectoral solution of borderline cases
Administrative and technical support (incl. IT infrastructure)
Areas for improvementAreas for improvement
Public consultationsGeneral (2008)
IVD Directive (2010)
Impact assessmentOngoing
Commission proposalsCWP 2011 1st semester 2012
Ordinary legislative procedureEuropean Parliament and Council
Revision of the regulatory
framework for medical devices
Revision of the regulatory
framework for medical devices
More information
http://ec.europa.eu/consumers/sectors/
medical-devices/index_en.htm
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