11 May, Geneva The Regulation of medical devices in the European Union Carlo Pettinelli Director European Commission DG Internal Market, Industry, Entrepreneurship and SMEs 1
The EU single market for medical devices 1. EU (28 Member States) 2. EFTA/EEA: Norway, Liechtenstein, Iceland 3. Turkey 4. Switzerland 2
Some figures on the EU medical device sector Over 500 000 types of medical and in vitro diagnostic devices on the market Over 500 000 people employed in about 25000 companies, most of which are micro, small and medium sized enterprises 100 billion in annual sales (EU market) 6-10% of annual sales is re-invested in research every year 3
How medical devices are currently regulated within the EU? Same rules applied for the whole EU transposed into National legislation Directive 90/385/EEC on active implantable medical devices Directive 93/42/EEC on medical devices Directive 98/79/EC on in vitro diagnostic medical devices (IVDs) Free circulation of medical devices within the EU Also applied in Iceland, Liechtenstein, Norway, Switzerland, Turkey 4
The New Approach for regulating products Key Features 1) Essential requirements (safety, performance, etc.) set out in the legislation 2) Harmonised standards detailing technical solutions to meet the essential requirements (voluntary, manufacturers can use other methods) confer presumption of conformity with the essential requirements for products 3) CE Marking - indicates the conformity of the product with the legislation 4) Division of responsibilities along the distribution chain 5
5) Conformity assessment procedures ("Modules") Risk based approach Low risk products require self-declaration by the manufacturer Higher risk products require third-party assessment by Notified Bodies 6) Competence, impartiality and independence criteria and obligations for notified bodies carrying out third-party assessment when required are laid down in the legislation 7) Market surveillance Member States required to control the market 6
Revision of the EU Medical Devices Legislation - Background Directive 90/385/EEC on active implantable medical devices Directive 93/42/EEC on medical devices Regulation on medical devices Directive 98/79/EC on in vitro diagnostic medical devices Regulation on in vitro diagnostic medical devices 7
State of play and next steps 26 September 2012: adoption of the two Commission proposals on medical devices and IVDs 5 April 2017: Final adoption of the new Regulations 5 May 2017: Publication of the new Regulations in the EU Official Journal To be progressively applied over the 3 years (Medical Devices) and 5 years (IVDs) thereafter 8
Main features of the new texts (1) Clarification of the scope and of the obligations of economic operators Stricter pre-market assessment of high-risk devices with the involvement of a pool of experts at EU level. Reinforcement of the criteria for designation and of the oversight of notified bodies in charge of certifying medical devices. Introduction of a new risk classification system for in-vitro diagnostic medical devices based on international guidance. Reinforcement of the rules on clinical investigation, including an EUwide coordinated procedure for the authorisation of clinical investigation on medical devices taking place in more than one Member State. 9
Main features of the new texts (2) Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system allowing to trace the device from its manufacturer through the supply chain to the final user. Improved coordination between Member States in the fields of vigilance and market surveillance. Role and responsibilities of economic operators. Certain new obligations for authorised representatives. 10
Thank you for your attention 11