STATE OF THE ART AND STATE OF THE ART AND PERSPECTIVES IN MEDICAL DEVICE PERSPECTIVES IN MEDICAL DEVICE

LEGISLATIONLEGISLATION

STATE OF THE ART AND STATE OF THE ART AND PERSPECTIVES IN MEDICAL DEVICE PERSPECTIVES IN MEDICAL DEVICE

LEGISLATIONLEGISLATION

3rd National Conference on Medical devicesRoma, 13th April 2010

Sabine LecrenierHead of Unit

Cosmetics and medical devices

This contribution was prepared by Ms Sabine Lecrenier, DG SANCO © European Union, 2010 .The views expressed in this contribution are those of the author and do not necessarily reflect the official position of the European Commission.Neither the European Commission nor any person acting on its behalf is responsible for any use that might be made of the following information

Directive 2007/47/EC = improvements introducedDirective 2007/47/EC = improvements introduced

Clinical evaluation

Conformity assessment procedures

Consultation for combination products

New essential requirements

Decisions on qualification aspects

Directive 2007/47/EC = implementing measuresDirective 2007/47/EC = implementing measures

EUDAMED Decision

E-labelling

AIMDs manufactured utilizing tissues of animal origin

Vigilance procedures

Reprocessing of medical devices Reprocessing of medical devices

2007: Public consultation

2008: Workshop

2009/2010 : SCENIHR opinion

Sept. 2010 : EC report to the EP and to the

Council

vCJD assaysvCJD assays

Amendment of Annex II List A of Directive 98/79/EC (addition of blood screening, diagnostic and confirmatory vCJD assays)

Common Technical Specifications for blood screening vCJD assays

Recast of the medical devices DirectivesRecast of the medical devices Directives

Structural shortcoming unsolved

Need for a more systemic revision of the regulatory framework

Recast of the medical devices Directives – Public consultationRecast of the medical devices Directives – Public consultation

200 responses

Many concerns shared by Member States and stakeholders…

… but more time was needed

Recast of the medical devices Directives – AimsRecast of the medical devices Directives – Aims

High level of health protection in a properly functioning Internal Market

International trade

Global challenges

ConclusionConclusionDirective 2007/47/EC

Important improvementsImplementing measures

… but still structural shortcoming unsolved …

Proposed RecastHigh level of health protectionProper functioning of the Internal

MarketCompetitiveness and innovation

Thank you for your attentionThank you for your attention !!

Sabine LECRENIER Sabine LECRENIER Head of Unit « Cosmetics and Medical Devices »Head of Unit « Cosmetics and Medical Devices »

European CommissionEuropean CommissionDG Health & ConsumersDG Health & Consumers

sanco-cosmetics-and-medical-devices@ec.europa.eu

http://ec.europa.eu/enterprise/medical_devices/