Regulatory Framework for Medical Device
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- Prudence Stewart
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1 Regulatory Framework for Medical Device International Seminar Safety of Health Products French Ministry of Labour, Employment and Health Paris, 26 May 2011 Peter Bischoff-Everding European Commission
2 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
3 EU regulatory framework 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)
4 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 not pharmacological, immunological or metabolic
5 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)
6 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
7 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
8 Basic principles of device regulation Clinical evaluation Required for all medical devices Critical analysis of clinical data Demonstration of conformity with Essential Requirements Scientific literature Clinical investigations (GCP) Required for implantable and class III MD Subject to national notification/approval
9 Basic principles of device regulation Quality management system (QMS) Consistent compliance with regulatory requirements (Voluntary) harmonized standards Presumption of conformity with Essential Requirements ISO, IEC, CEN, CENELEC
10 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
11 Basic principles of device regulation Labelling Label Instructions for use CE-marking Registration and Listing Manufacturers / authorised representatives MD of class I
12 Basic principles of device regulation Post-market safety Obligations of manufacturers Post-market surveillance plan, incl. post-market clinical follow-up Reporting of serious incidents to CA Application of Field Safety Corrective Actions (FSCA) Communication of FSCA to users by means of Field Safety Notice (FSN)
13 Basic principles of device regulation Post-market safety Responsibilities of competent authorities Central recording and evaluation of reported incidents and FSCA Information sharing between competent authorities (NCAR system) Market surveillance Measures against non-compliant MD Measures against dangerous products
14 Flexibility Timeliness Strengths Cost-effectiveness Supportive for innovation Balance between pre- and postmarket control Manageable for SMEs
15 Areas for improvement Oversight of Notified Bodies Designation and monitoring Uniform standards of conformity assessments
16 Areas for improvement Clinical investigations Introduction of the concept sponsor Coordination of technical assessment for multi-national CI
17 Areas for improvement Post-market safety Consistent and timely reactions to safety issues Coordination of analysis of serious incidents and market surveillance activities
18 Areas for improvement Transparency Economic operators and medical devices Summary device information Traceability of devices Internet sales
19 Areas 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)
20 Revision of the regulatory framework for medical devices Public consultations General (2008) IVD Directive (2010) Impact assessment Ongoing Commission proposals CWP st semester 2012 Ordinary legislative procedure European Parliament and Council
21 More information medical-devices/index_en.htm
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