1. Health and Consumers Health and Consumers Introduction to the new Medical Device Regulations and their impact on medical software DG for Internal Market, Industry, Entrepreneurship and SMEs European Commission

2. Health and Consumers Health and Consumers State of play and timeline  26 September 2012: adoption of the two Commission proposals on medical devices and IVDs  2 April 2014: European Parliament adopts its first reading  5 October 2015: Council agrees on a 'general approach'  15 June 2016: Council and Parliament reach political agreement on the two Regulations, endorsed by Health Ministers on 17 June 2016. 2

3. Health and Consumers Health and Consumers Next steps: timeline  Formal Council political agreement in the autumn followed by a legal linguistic check  Adoption of the Council's first reading position end 2016  EP second-reading vote end 2016/ early 2017  Entry into force on the twentieth day after its publication in the OJ  Date of application: from three (MD)/five (IVD) years after entry into force 3

4. Health and Consumers Health and Consumers Key derogations (1) 6 months after entry into force Requirements on Notified Bodies Designation of Competent Authority Establishment of the MDCG 12 months after entry into force Cooperation among Competent Authorities 6 months before the date of application Designation of reference laboratories for IVDs 4

5. Health and Consumers Health and Consumers Key derogations (2) 0-18 months after the date of application Registration of devices 0-7 years after the date of application Coordinated procedure for clinical investigation 2/4 years after date of application Certificates issued under old Directives: maximum period of validity of 4 years (MD) and 2 years (IVD) after entry into application 3/5 years after date of application Devices lawfully placed on the market under old Directives prior to the date of application may continue to be made available on the market or put into service until five years (IVD three years) after that date. 5

6. Health and Consumers Health and Consumers Main changes 1/2  Stricter pre-market control of high-risk devices with the involvement of a pool of experts at EU level;  The reinforcement of the criteria for designation and processes for oversight of notified bodies in charge of certifying medical devices;  The inclusion of certain aesthetic products which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;  The introduction of a new risk classification system for diagnostic medical devices based on international guidance; 6

7. Health and Consumers Health and Consumers Main changes 2/2  Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system;  Stricter and clearer obligations for economic operators;  The introduction of an EU-wide requirement for an “implant card” to be provided to patients containing information about implanted medical devices;  The reinforcement on the rules on clinical data, including an EU-wide coordinated procedure for the authorisation of multi- centre clinical studies on device;  The reinforced requirements for manufacturers to collect data about the real-life use of their devices;  Improved coordination between Member States in the fields of vigilance and market surveillance. 7

8. Health and Consumers Health and Consumers Focus on medical software

9. Health and Consumers Health and Consumers Main issues 1. Definition of "medical device" 2. Classification rules 3. General safety and performance requirements 4. UDI requirements for software 9

10. Health and Consumers Health and Consumers Definition ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of: - diagnosis, prevention, prediction, prognosis, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, - investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, - providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices for the purpose of control or support of conception shall be considered medical devices. 1. Definition of "medical device"

11. Health and Consumers Health and Consumers 2. Classification rules on software Rule 10a (new) Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, is in class IIa, except if such decisions have an impact that may directly or indirectly cause: - the death or an irreversible deterioration of the state of health, in which case it is in class III; - a serious deterioration of the state of health or a surgical intervention, in which case it is in class IIb. Software intended to monitor physiological processes is in class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb. All other software is in class I.

12. Health and Consumers Health and Consumers 3. General safety and performance requirements repeatability, reliability and performance according to the intended use the principles of development life cycle, risk management, verification and validation the use of software in combination with mobile computing platforms IT security measures, including protection against unauthorised access

13. Health and Consumers Health and Consumers 4. UDI requirements for software UDI obligations apply to software which are commercially available on their own and software which are medical devices in themselves Need for a new UDI/DI: changes to a)original intended performance/effectiveness b)safety or intended use c) interpretation of data Software identification is the manufacturing control mechanism Specific placement criteria

14. Health and Consumers Health and Consumers Thank you for your attention! European Commission Health and Consumers Directorate-General Health Technology and Cosmetics Unit http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm