1. Workshop on Accreditation of bodies certifying medical devices - Kiev 2014 - CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA

2. The notion of Technical Regulations and their interrelation with the requirements of the European Directives: 93/42/EEC “Medical Devices Directive” 90/385/EEC “Active Implantable Medical Devices Directive” 98/79/EC “In Vitro Diagnostic Medical Devices Directive”

3. THE LEGAL FRAMEWORK IN THE FIELD OF MD -New Approach Directives (directives providing for CE marking) where the requirements are laid down -other New Approach and/or Global Approach Directives where a Notified Body must / must not be involved -many other EU Directives and other Legislation and -there exist connected legislations which means 3 new EU Regulations: 920/2013, 722/2012, 207/2012. In Romanian legislation EU Directives are transposed by Government Decisions which contain Technical Regulations in the field of MD

4. NEW APPROACH MEANS harmonized requirements:

5. 1.AIMD Directive 90/385/EEC on active implantable medical devices This Directive shall apply to active implantable medical devices.

6. 2.MDD Directive 93/42/EEC on medical devices amended by Directive 98/79/EC, Directive 2000/70/EC, Directive 2001/104/EC, Regulation EC/1882/2003 and Directive 2007/47/EC + Directive 2003/12/EC + Directive 2003/32/EC + Directive 2005/50/EC This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

7. 3.IVD Directive 98/79/EC on in vitro diagnostic medical devices amended by Regulation EC/1882/2003, Regulation EC/596/2009 and Directive 2011/100/EC + Commission Decision 2002/384/EC amended by 2009/886/EC and 2011/869/EU This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.

8. THE NEW EU REGULATIONS As a regulation, it does not need to be transposed into national legislations by the individual EU states, as against directive, the latter leaving the Member States too much wiggle room for own interpretation. !!!!! The application of the regulations is mandatory in all EU Member States

9. SIGNIFICANCE OF THE NEW REGULATIONS The measures proposed by the European Commission are to serve for the improvement of the safety of medical devices. The Commission thus intends to fulfil its obligation to re- establish patient confidence in the medical devices sector, which had been lost to a significant degree as a result of the breast implant scandal and other events. (in which the French manufacturer substituted approved medical- grade silicone with industrial-grade silicone that resulted in rupture of the implants and systemic health problems, including death)

10. THE MAIN PURPOSE A level playing field across Europe in approach to CE Certification of Medical Devices Improvements to achieve more harmonisation, while leaving the current ‘new approach’ proportional principles intact Ultimate goal – Patient welfare and safety! BUT do not compromise innovation and new device development within the Industry.

11. THE NEW EU REGULATIONS IN THE FIELD OF MD

12. 1.COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices & Commission RECOMMENDATION 2013/473/EU on the audits and assessments performed by notified bodies in the field of medical devices

13. THE NEW PROVISIONS -define the criteria to be met by the notified bodies responsible for supervising the manufacturer of medical devices -a control made in one Member State is valid for the whole EU (there are about 80 notified bodies for medical devices in the EU) -the Recommendation clarifies the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector, which covers some 10,000 types of products, from plasters to pacemakers.

14. THE JOINT PLAN FOR IMMEDIATE ACTION The measures were announced in the Joint Plan for immediate action agreed between the Commission and the EU Member States in February 2012. The plan focuses on -the functioning of notified bodies -the surveillance by the Member States of the products on the market -EU coordinated investigations and responses to problems with specific devices -improved transparency and communication between Member States, industry, health professionals and notified bodies Most of the actions agreed upon have now been implemented or are under implementation !!!

15. ARTICLE 1 : NEW DEFINITIONS IN THE FIELD OF MD: ‘on-site assessment’ ‘surveillance on-site assessment’ ‘observed audit’ ‘functions’ ‘subcontracting’

16. DESIGNATION Prescribed Application Form As well as the Designating Authorities (DA), representatives from 2 other MSs plus the Commission will participate in the assessment (MSs will need to make resource available for this) Member States shall make available a group of assessors Application open for review by all MSs if they so wish Validity of designation shall be limited up to a maximum of 5 years

17. EXTENSION AND RENEWAL Extensions and Renewals must follow the same procedure as for Designations All existing NBs: renewal until 14 October 2016

18. SURVEILLANCE AND MONITORING DA can carry out unannounced or short- notice on site Assessments Commission Investigations Commission may investigate cases regarding competence Where there is evidence of the NB no longer meeting the requirements, the Commission may request the DA to take the necessary corrective actions

19. DESIGNATING AUTHORITIES DAs shall consult each other and the Commission Shall have sufficient number of competent personnel

20. IN ANNEX 1, we will find interpretation of the criteria set out in Annex 8 from Directive 90/385/EEC and in Annex XI from Directive 93/42/EEC regarding the organization, function and duties of the conformity assessment body. Independence and Impartiality Subcontracting Competence (including clinical) Quality Management System Confidentiality

21. In ANNEX II, we will find the „Application form to be submitted when applying for designation as notified body“ Legal Status and Organisational Structure Independence and Impartiality Confidentiality Liability Financial Resources Quality System Resource Requirements including Subcontractors Process

22. COMMISSION RECOMMENDATION 2013/473/EU

23. ANNEX I PRODUCT, Assessment Verify that the product is a medical device Verify compliance of the device with the relevant ERs Risk Management Pre-clinical data Clinical evaluation Post market clinical follow up

24. ANNEX II QUALITY SYSTEM Assessment Verification of products covered including an unequivocal product identification system Review of technical documentation of Class IIa and Class IIB products Verification of manufacturers’ procedures for clinical evaluations and post market clinical follow up Verification that experience gained in the post production phase, in particular user complaints and vigilance data, is systematically collected and evaluated

25. OUTSOURCING Manufacturers now have to fulfil the obligations themselves They need to have access to the full technical documentation and have a quality system in place themselves

26. UNANNOUNCED AUDITS At least once every 3 years Be no less than 1 day and be executed by at least 2 auditors Can include subcontractors During the audit a device should be sampled and thoroughly reviewed for compliance Testing of devices need to be performed by the NB or under their supervision Check at least 2 critical processes Unannounced audits should be foreseen in the contractual arrangements.

27. 2.COMMISSION REGULATION (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin

28. ANIMAL TISSUES AND OTHER MATERIALS OF ANIMAL ORIGIN Modern medical devices incorporate a range of materials into finished products, including in some instances animal tissues and other materials of animal origin. Although animal materials can provide therapeutic and biocompatibility advantages over non-animal materials, their use in medical devices also introduces the risk of disease transmission from animals to humans.

29. THE SO-CALLED TSE DIRECTIVE (2003/23/EC) (TRANSMITTING SPONGIFORM ENCEPHALOPATHY)2003/23/EC In response to increasing concerns about disease transmission from medical devices incorporating animal products, the EC published the so-called TSE Directive (2003/23/EC) in 2003.2003/23/EC By publishing its Regulation (EU) No. 722/2012, the EU has now established a new regulatory framework for utilising tissues of animal origin in Medical Devices and Directive 2003/32/EC is repealed with effect from 29 August 2013.tissues of animal origin in Medical Devices References to the repealed Directive are to be construed as references to this Regulation.

30. ADDITIONAL COMPLIANCE REQUIREMENTS ON MEDICAL DEVICE MANUFACTURERS In support of this Directive, the Commission has recently issued revised regulations (722/2012) regarding the use of TSE-relevant animal tissues and products found in a wide range of medical devices.722/2012 The new regulations impose additional compliance requirements on medical device manufacturers, including risk assessment and risk management practices intended to reduce the potential risk of TSE transmission. risk management The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Directive 90/385/EEC. For manufacturers, the requirements of the EU’s Regulation 722/2012 are applicable to any device approved for placement on the market as of August 29, 2013.

31. THE AIM OF THE REGULATION to maintain a high level of safety in the European Market and to ensure health protection against the risk of transmitting animal spongiform encephalopathy - TSE (Mad Cow Disease) to patients or other persons via medical devices (animal spongiform encephalopathy = debilitating disease affecting the brains of susceptible species, including cattle, sheep and goats, and which can be transmitted to humans through contact with TSE-infected animal tissues and fluids)

32. APPLICABILITY This Regulation shall apply to animal tissues, as well as their derivatives, originating from bovine, ovine and caprine species, deer, elk, mink and cats collagen, gelatine and tallow

33. NEW DEFINITIONS In the Article 2 we will find NEW DEFINITIONS, in addition to the definitions set out in Directive 93/42/EEC, for: ‘cell’ ‘tissue’ ‘derivative’ ‘non-viable’ ‘TSE’ (transmissible spongiform encephalopathies) ‘TSE infectious agents’ ‘reduction, elimination or removal’ nactivation’ ‘source country’ ‘starting materials’

34. THE MAIN MEASURES PROVIDED FOR IN THIS REGULATION The Regulation sets out: -risk analysis and risk management -the sourcing of materials used in medical devices -minimising the risk of transmitting animal spongiform encephalopathy agents -NB must have the necessary expertise -MS shall regularly verify that those bodies -MS shall notify the Commission and the other Member States -NB verifies that the benefits of the device outweigh the residual risks -manufacturers should consult with a Notified Body at the earliest possible stages of new product development to determine how these requirements will impact design considerations.Notified Body -summary evaluation report -comments -NB: an explanation as regards this consideration -NB: any due justification not to take account of one or more of the comments received NB: their final decisions

35. 3.COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 electronic instructions for use of medical devices

36. COMMISSION REGULATION (EU) No 207/2012 Defines electronic instructions for use (EIFUs) as instructions available from a : web site supplied in portable electronic media (e.g., CD, DVD, USB drives) displayed in electronic form on the product screen. In the latter two cases, manufacturers are also required to provide instructions on a Web site.

37. THE CONDITIONS UNDER WHICH THE INSTRUCTIONS FOR USE OF THE FOLLOWING MEDICAL DEVICES COVERED UNDER DIRECTIVE 90/385/EEC AND DIRECTIVE 93/42/EEC MAY BE PROVIDED IN ELECTRONIC FORM:

38. THE CONDITIONS: 1. Active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device. 2. Implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device. 3. Fixed installed medical devices covered by Directive 93/42/EEC. Medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built- in system visually displaying the instructions for use. 4. Stand-alone software covered by Directive 93/42/EEC.

39. !!!! In Vitro Diagnostic (IVD) medical devices covered by the Directive 98/79/EC are NOT INCLUDED in this Regulation

40. THE PURPOSE OF THE REGULATION is to reduce the environmental burden and improve competitiveness by reducing costs whilst at the same time maintaining safety. The provision of instructions for use in an electronic form can be beneficial for certain professional users.

41. DEFINITIONS

42. 1.Instructions for use 2.Instructions for use in electronic form 1. “Instructions for use” means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken as outlined in the relevant parts of point 15 of Annex I to Directive 90/385/EEC and of point 13 of Annex I to Directive 93/42/EEC. 2. “Instructions for use in electronic form” means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or available through a website.

43. 3.Professional users 4.Fixed installed medical devices 3. “Professional users” means persons using the medical device in the course of their work and in the framework of a professional healthcare activity. 4. “Fixed installed medical devices” means devices and their accessories which are intended to be installed, fastened or otherwise secured at a special location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility.

44. CONDITIONS Manufacturers may provide EIFU on condition that: -they are intended for exclusive use by professional users and the use by other persons is not reasonably foreseeable; if the device design requires that a part of the instructions is intended to be provided to the patient, the regulation requires that part to be in paper form. -they have undertaken a risk assessment and the level of safety obtained by providing the instructions for use in paper form would be maintained or improved -any parts of the instructions for use intended to be passed on to the patient are also available in paper form. -the text used (which can contain symbols and graphics) is entirely the same as would be provided in paper form; video and audio files may be offered in addition to the text

45. RISK ASSESSMENT A risk assessment of electronic instructions for use will be conducted covering the following elements the knowledge and experience of the iusers the characteristics of the environment in which the device will be used the knowledge, experience of the user and their level of familiarity with the hardware and software the access of the user to electronic resources the safety and back up mechanisms in the event of hardware or software fault the foreseeable medical emergency situation requiring a paper format the impact caused by the temporary availability of the website or Internet, as well as any safety measures

46. WEBSITE PROVISION Where instructions for use are provided in other electronic forms they should also be made accessible to users through a website. Where provided on a website the instructions for use should : be in a commonly used format that can be read with freely available software be protected against hardware and software intrusion be provided in such a way that server and display errors are reduced as far as is possible mention in which EU languages are provided fulfil the requirements of Directive 95/46/EC as amended include all previous versions issued in electronic form

47. CONCLUSIONS

48. THE REVISED REGULATORY FRAMEWORK FOR MEDICAL DEVICES AT THE EUROPEAN LEVEL A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices); A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regardingin vitro diagnostic medical devices). For more information: http://ec.europa.eu/health/medical- devices/index_en.htmhttp://ec.europa.eu/health/medical- devices/index_en.htm

49. WHY IS THE COMMISSION PROPOSING NEW RULES? The existing EU legislation, dating back to the 1990s, has not kept pace with scientific progress in the past 20 years ; like every regulatory regime dealing with innovative products it needs regular revision EU Member States interpret and implement the current rules in different ways, which leads to different levels of patient and public health protection in the EU Greater transparency is needed : patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices and in vitro diagnostic medical devices have been assessed

50. ARE THE COMMISSION PROPOSALS A RESPONSE TO THE PIP BREAST IMPLANTS SCANDAL? The Commission had been working on the revision of the medical device legislation before the PIP scandal occurred. However, the Commission has carefully analysed the PIP scandal in order to ensure that the proposals are robust enough to avoid such problems happening again.

51. WHAT ARE THE NEXT STEPS? The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019.

52. THANK YOU FOR YOUR ATTENTION !