1. Health and Consumers Health and Consumers Introduction to the new regulatory framework for medical devices and in vitro diagnostic medical devices DG for Internal Market, Industry, Entrepreneurship and SMEs European Commission

2. Health and Consumers Health and Consumers Communication on safe, effective and innovative MDs and IVDs Medical devices package Regulation on MDs Regulation on IVDs

3. 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. 3

4. 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 4

5. 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 5

6. 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. 6

7. Health and Consumers Health and Consumers Scope

8. Health and Consumers Health and Consumers Scope: Regulation on medical devices 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.

9. Health and Consumers Health and Consumers Scope: Regulation on medical devices Extension of the scope to:  Certain implantable and other invasive products regardless of a medical or non-medical (e.g. aesthetic) purpose (see Annex XV)  Medical devices manufactured utilising derivatives of non- viable human tissues or cells  Reprocessed single-use medical devices

10. Health and Consumers Health and Consumers Scope: Regulation on medical devices Clarification of the scope regarding:  Internet sales  Medical devices used for diagnostic or therapeutic services offered at a distance  Excluded: food and products containing or consisting of viable biological substances (e.g. living micro-organisms)

11. Health and Consumers Health and Consumers Scope: Regulation on IVDs Definition ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: – concerning a physiological or pathological state; – concerning congenital physical or mental impairments; – concerning the predisposition to a medical condition or a disease; – to determine the safety and compatibility with potential recipients; – to predict treatment response or reactions; – to define or monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. For the purposes of this Regulation, ‘specimen receptacle’ means devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

12. Health and Consumers Health and Consumers Scope: Regulation on IVDs Clarification of the scope regarding:  Internet sales  IVDs used for diagnostic or therapeutic services offered at a distance

13. Health and Consumers Health and Consumers Scope: MD and IVD Regulations Regulatory status of products  Possibility or (under certain conditions) obligation for the Commission to adopt decisions determining whether a specific product falls in the scope of the Regulation: on its own initiative or upon a duly substantiated request by a Member State  Involvement of relevant stakeholders and consultation of EMA, ECHA and EFSA, as relevant

14. Health and Consumers Health and Consumers Horizontal aspects

15. Health and Consumers Health and Consumers 'In house' exemption  Exemption of devices manufactured and used in the same health institution from the Regulation but subject to the general safety and performance requirements in Annex I  Conditions: No transfer to another legal entity Appropriate quality management system The health institution draws up and maintains a documentation for the manufacture of the device It justifies in its documentation that the patient's needs cannot be met by a marketed device

16. Health and Consumers Health and Consumers Claims  Prohibition to give the user or patient any indication that may mislead them as regards the device's intended purpose, safety and performance by: Ascribing functions and properties the product does not have Creating a false impression regarding treatment or diagnosis, functions or properties the product does not have Failing to inform of a risk associated with the use of the product accoding to its intended purpose Suggesting uses of the product other than those indicated in the intended purpose

17. Health and Consumers Health and Consumers Role of economic operators  Clear set of obligations and responsibilities Manufacturers  Quality management system  Post-market surveillance system  Technical documentation  Qualified person  Financial coverage in case of liability for defective products Authorised representatives  Written mandate  Minimum tasks  Qualified person  Liability for defective products

18. Health and Consumers Health and Consumers Role of economic operators  New rules regarding Importers  Responsible person in EU for placing on the market of products from outside EU  Appropriate check of conformity of products before placing on the market in EU Distributors  Appropriate check of conformity of products before making available  Repackaging and/or relabelling

19. Health and Consumers Health and Consumers Identification and traceability  Supply chain  Identification of economic operators up and down the supply chain (particularly for Class III implantable devices)  Introduction of the Single Registration Number for manufacturers, authorised representatives and importers  Unique device identification (UDI)  Introduction of a UDI system  UDI database integrated in future EUDAMED

20. Health and Consumers Health and Consumers Transparency  Publicly available information in EUDAMED regarding  Devices on the EU market  Summary of Safety and Clinical Performance Data for high risk devices  Manufacturers, authorised representatives and importers  Certificates issued by notified bodies  Clinical investigations / clinical performance studies  Field safety notices

21. Health and Consumers Health and Consumers EUDAMED: Processes of the Device lifecycle 2 nd module set 1 st module set Clinical Investigation / Performance Studies Actor registration Device & UDI registration NBs & Certificates Vigilance Market Surveillance Device placed on the market 21

22. Health and Consumers Health and Consumers Notified bodies  Tightened supervision of Notified Bodies  Reinforced minimum requirements (independence, impartiality, competence, resources and processes)  New process for designation and monitoring ('joint assessments')  Review of notified body assessment of technical documentation and clinical evaluation  Clinical evaluation consultation for certain high-risk devices

23. Health and Consumers Health and Consumers Notified bodies  Tightened conformity assessment requirements  Conformity assessment procedures (see specific slides)  Annual surveillance audits  Unannounced audits at least every five years and sample testing  Rotation of auditors

24. Health and Consumers Health and Consumers General safety and performance requirements  Essential requirements aligned with GHTF  Labelling requirements aligned with GHTF  New requirement for invasive medical devices containing hazardous substances

25. Health and Consumers Health and Consumers Clinical data  Clinical investigations / interventional performance studies  Procedures aligned with proposed rules on clinical trials on medicinal products  Provisions on informed consent and protection of vulnerable subjects  Option for single application by sponsor in case of multi-Member State studies (longer transitional period)  Clinical evaluation / performance evaluation  Continuous process, incl. post-market (clinical) follow-up

26. Health and Consumers Health and Consumers Post-market surveillance  To gather, record and analyse relevant data on the quality, performance and safety of devices, to draw the necessary conclusions and determine any preventive and corrective actions  Post-market surveillance plan  Post-market surveillance report  Periodic safety update report

27. Health and Consumers Health and Consumers Vigilance and market surveillance  Vigilance  EU vigilance portal  Central reporting of serious incidents and field safety corrective actions  Reporting of FSCA outside EU regarding devices placed also on the EU market  Trend reporting  Enhanced coordination between authorities  Extended role of notified bodies

28. Health and Consumers Health and Consumers Vigilance and market surveillance  Market surveillance  Clearer rights and obligations of market surveillance authorities (e.g. in-market controls)  Clearer procedures for national provisional measures  Mutual information and control

29. Health and Consumers Health and Consumers Governance  Reinforced coordination  Medical Device Coordination Group (MDCG) - Experts representing national authorities (MD and IVD) - European Commission: Chair  Technical, scientific and logistic support -European Commission: DG GROW & Joint Research Centre -Expert panels / expert laboratories / reference laboratories  Committee on Medical Devices  "Comitology" Committee under Reg. 182/2011  For medical devices and IVDs together

30. Health and Consumers Health and Consumers Specific aspects regarding medical devices other than IVDs

31. Health and Consumers Health and Consumers Classification Adaptation of classification rules, e.g.  Stand alone software (new rule 10a)  IVF/ART (rule 3)  Spinal disc replacements and surgical meshes (rule 8)  Human tissue engineered devices (rule 17)  Devices with free nanoparticles (rule 19)  Substance-based devices (rule 21)  Invasive devices intended to administer medicinal products by inhalation (rule 22)

32. Health and Consumers Health and Consumers Conformity assessment  Class I: Self-certification (unless sterile or having a measuring function or reusable surgical instrument)  Class IIa & IIb: assessment of technical documentation on sampling basis  Class III: assessment of the technical documentation & adequate testing (or type examination)  Class III implantables and IIb administering a drug: 'scrutiny'  MD with ancillary medicinal substance: streamlined consultation of pharmaceutical authority  For human tissue engineered MD: consultation of authority responsible for human tissues & cells  For substance-based devices that are systemically absorbed in order to achieve their intended purpose: consultation of pharmaceutical authority

33. Health and Consumers Health and Consumers Clinical investigations  Well-established technologies Clinical investigations required for class III devices and implantable devices unless: 1)Iteration of a device by the same manufacturer, equivalence and sufficient clinical evaluation 2)Equivalence and contract with the original manufacturer 3)Placed on the market under the old legislation, clinical evaluation based on sufficient clinical data and complies with CS / lower-risk implants clinical evaluation based on sufficient clinical data and complies with CS  Minimum requirements for clinical investigations performed for non-regulatory purposes

34. Health and Consumers Health and Consumers Specific aspects regarding IVDs

35. Health and Consumers Health and Consumers Current system→ positive list i.e. Annex II to Directive 98/79/EC = no longer adapted to fast pace of technological progress e.g. vCJD assays Risk classification

36. Health and Consumers Health and Consumers New system → risk-rule based classification*  4 classes  A: low individual risk and low public health risk  B: moderate individual risk and/or low public health risk  C: high individual risk and/or moderate public health risk  D: high individual risk and high public health risk  7 classification rules Risk classification * Based on GHTF/SG1/N045:2008

37. Health and Consumers Health and Consumers Conformity assessment Conformity assessment -Class B, C and D : proportionate involvement of a Notified Body -Class A: self-certification (unless sterile or having a measuring function) + -Class D : involvement of a Reference Laboratory to verify compliance with the applicable Common Specifications (CS) + batch verification / 'scrutiny' where no CS and first certification -Companion diagnostics: consultation procedure with a pharmaceutical authority

38. Health and Consumers Health and Consumers  Reinforcement of performance evaluation requirements  Scientific validity  Analytical performance  Clinical performance  Specific requirements for certain types of performance studies (e.g. application & registration) Performance evaluation

39. 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