1. CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA

2. ROLE AND VALUE OF THE HEALTH CARE INSTITUTIONS FOR ACCREDITATION

3.  COMPETENT AUTHORITY (CA)  NOTIFIED BODY (NB)  ACCREDITATION BODY (AC)  POLITICAL ORGANIZATION

4.  Competent Authority (CA) : NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES (NAMMD) - responsible for control & surveillance  Political Organization : MINISTRY OF HEALTH - responsible for policy  Notified Body (NB) : TECHNICAL OFFICE FOR MEDICAL DEVICES CERTIFICATION (OTDM) - responsible for certification of medical devices  Accreditation Body (AC) : RENAR (national accreditation body) responsible for accreditation of notified body

5. 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

6.  ‘conformity assessment body’ = a body which performs calibration, testing, certification and inspection activities under Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council (2);  ‘notified body’ = a conformity assessment body which has been notified by a Member State in accordance with Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC  ‘accreditation body’ = the sole body in a Member State that performs accreditation with authority derived from the State as laid down by Article 2(10) of Regulation (EC) No 765/2008  ‘designating authority’ = the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified bodies under Directive 90/385/EEC or Directive 93/42/EEC  ‘competent authority’ = the authority(ies) in charge of market surveillance and/or of vigilance for devices

7. ROMANIAN COMPETENT AUTHORITY NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES (NAMMD)

8. responsible for CONTROL & SURVEILLANCE of medical devices market

9.  ensures implementation of medical devices policy  verifies compliance with technical regulations in this area  undertakes surveillance activities on the medical devices market in accordance with the legislation.

10.  - control by periodic check  - unannounced testings, assessments and inspections  The PURPOSE of market surveillance: to ensure that the provisions of EU directives are respected throughout the European Union

11.  necessary resources and capacity to conduct surveillance activities  necessary technical competence  staff with professional integrity IN ORDER TO  take all appropriate measures to limit or prohibit the movement on the market of the medical devices that do not meet the essential requirements provided in the directive  to take actions on nonconforming products or against those who affixed the CE marking

12.  to provide the CA the declarations of conformity and technical documentation of the medical devices placed on the market

13.  1. responsible for the introduction and putting into service of MD under the conditions imposed by the directive : In Romania, it is permitted to place on the market and put into service ONLY the MD which are in accordance with Romanian Law and have the Eurpean mark of conformity CE  2. takes the final decision when there is a dispute regarding the classification of a MD  3. by exception the NAMMD can authorize, based on a valid application, the introduction on the market and the putting into service on the Romanian territory of some individual devices that have not yet been certified and the use of which is in the interest of health protection  4. permanently collaborates with the European Commission

14. 5. ensures the national database on Romanian manufacturers of MD and on the products placed on the market 6.decides on clinical investigations of MD on human subjects 7. applies the criteria set out in the new EU legislation for the designation of the notified bodies 8. monitors the NB (when the NAMMD finds that a notified body no longer meets the criteria that led to the designation, it will withdraw the notification and will inform Member States of the European Union and the European Commission on this decision) 9. determines the contraventions provided by the Romanian legislation transposing the Directive and applying the sanctions

15.  to control the compliance with technical regulations regarding medical devices  to determine contraventions  to apply the sanctions provided by the legislation through which the European directives were transposed in the area.

16.  -elaborates technical procedures in the field of MD  -issue an approval letter for conducting marketing activities, distribution, providing of services  -assess and/or audit, upon request, individuals or legal entities which ask approval for conducting marketing activities, distribution, providing of services  -ensures, by examination and testing, the control of MD in use  -ensures performance assesment of MD  -informs from time to time the Ministry of Health regarding it’s activity in the field of MD

17.  The second-hand medical devices provided free or for a fee, they can be marketed, put into operation and used only after NAMMD assess their performance and issue and approval letter.

18.  ONLY the SH medical devices which are in accordance with Romanian Law and have the European mark of conformity CE  = have undergone an evaluation of conformity complying with one of procedures set by European legislation (transposed into national legislation), by NAMMD.

19.  The NAMMD ensures the recording and evaluation of ANY INFORMATION regarding the signaling of one of the following incidents relating to the MD:  any malfunction or deterioration in the characteristics and / or performance of a device  any inadequacy in the labeling or instructions for use (which might lead to or might have led to death or serious deterioration of health of a patient or user)  any technical or medical reason connected with the characteristics or performance of a device for the reasons mentioned above, leading to systematic recall from the market by the manufacturer of the devices of the same type.

20.  comes into the responsibility of the medical personnel, medical units and the manufacturer &  NAMMD shall notify the device manufacturer or his authorized representative of the incident

21.  the NAMMD IMMEDIATELY INFORMS the European Commission and other EU Member States on measures that have been taken or are taken into account to minimize the recurrence these incidents

22. ROMANIAN NOTIFIED BODY (NB) TECHNICAL OFFICE FOR MEDICAL DEVICES CERTIFICATION (OTDM) responsible for CERTIFICATION of medical devices

23.  (OTDM) is the Romanian notified body with number NB 1868 at the European Commission http://ec.europa.eu/enterprise/newapproach/nand o/index.cfm?fuseaction=notification.html&ntf_id= 255010&version_no=3  Some information about the accreditation details are available in the PDF:  Notification of a Body in the framework of a technical harmonization directive on http://ec.europa.eu/enterprise/newapproach/nand o/index.cfm?fuseaction=notification.pdf&dir_id=1 3&ntf_id=255010

24.  Who is RESPONSIBLE for notification of medical devices conformity evaluation bodies ?????? = COMPETENT AUTHORITY (CA)  !!!! These bodies have to continuously take into account the criteria of the Directive

25.  tries to establish whether the body has -the technical competence & -the capacity to perform the conformity evaluation procedures

26. the necessary level of  independence  impartiality  integrity  ! The competence of the notified body must periodically be subjected to surveillance by the CA

27.  - the necessary STAFF (scientific staff who possesses experience and knowledge enough to evaluate the medical functionality and the performance of the devices for which it has been notified)  - the necessary FACILITIES for accomplishing technical and administrative tasks required for the evaluation and verification.  + New requirement for NB by New Regulation (UE) 920/2013 !!!

28.  !!! The staff remuneration must not depend on the number of inspections undertaken nor on the result of these inspections

29.  CA ensures that medical devices will be placed on the market after evaluating in an adequate manner their compliance with requirements of the directive and they will NOT COMPROMISE THE HEALTH AND SAFETY OF PATIENTS, users or third parties.  CA MAY WITHDRAW THE NOTIFICATION if the conformity evaluation body no longer meets the criteria provided in the Directive.

30. ROMANIAN ACCREDITATION BODY RENAR responsible for accreditation of notified body

31.  provide EUROPEAN AND INTERNATIONAL RECOGNITION of all conformity assessment services conducted by bodies in Romania

32. NEW PROVISIONS IN Article 9 OF REGULATION (UE) 920/2013: Cooperation with accreditation bodies

33.  - the accreditation body that has accredited a particular notified body is kept informed by the competent authorities on incident reports  - the accreditation body in charge of the accreditation of a particular conformity assessment body is kept informed by the designating authority of the Member State where the conformity assessment body is established on findings relevant for the accreditation  !!! The accreditation body shall inform the designating authority of the Member State where the conformity assessment body is established on its findings

34.  sets the application of specific requirements for the accreditation of bodies performing conformity assessment tasks in the field of MD

35.  This regulation shall apply to  all organizations under the jurisdiction of the Romanian state which request accreditation in order to be designated by the designating authority, as defined in the Regulation (EC) no. 765/2008  accredited and notified organizations in order to perform tasks for proving the compliance with Community and national law.

36. THANK YOU VERY MUCH FOR YOUR ATTENTION !