1. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Responsibility in the handling of medical devices Joanna Kilkowska Kiev, 27-28 November 2011

2. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Responsibility Ups…. I forgot to calibrate my glucometer ?!! What I was thinking about ?!! Where disappeared my responsibility ?!! What do you think – Is she responsible?

3. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Responsibility To be responsible for - what does it mean? Dictionary: - to hold somebody responsible for - to bear responsibility for something - to take responsibility for something - to be ready for punishment - somebody could trust on somebody - person: responsible, reliable, trustworthy - civil responsibility, civil liability, criminal responsibility

4. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl The scope of presentation medical device life cycle instruction for use economic operators EUDAMED COEN procedure

5. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 1. design 2. manufacturing 3. distribution/ supply chain 5. usage 6. post usage phase 4. installation

6. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Design Manufacturer: - -What is the intended purpose - -Who will be the user - -Will it be a single/ multi use device - -What are the main condition to operate such a device - -Will the medical devices be used in combination - -Does it contain substances/ medicines/ gases/ tissues - -Is there any additional risk of usage - -How device shall be prepared for transport - -Is there any special condition for storage/ transport needed - -…… - -…….

7. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Design 93/42/EEC – annex I „Essential requirements” ‘1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons.’ Safe design and construction Adequate protection (alarms included) Instruction for use/ label

8. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Design 93/42/EEC – annex I – „Essential requirements” ‘5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.’ ‘13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’

9. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Design 93/42/EEC – annex I – „Essential requirements” ‘ ‘ […] the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices.’ ‘ 13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.’

10. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Become an expert on symbols

11. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Design/ Usage Language requirements - -It is up to the MS to decide what are the language requirements - -manufacturer shall find out correct information to prepare IFU in a proper way, but majority of MS differentiate between user depending of their knowledge / training - -professional user - -lay person In Poland - devices which will be used on Polish territory shall have instruction for use in Polish unless they are intended for professional user - then English is allowed except information which has to be delivered to patient

12. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Directives do not contain requirements in this area (jet) Decision 768/2008/EC on a common framework for the marketing of products (preamble) „ (18) All economic operators are expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market.’ - manufacturer - authorised representative - importer - distributor

13. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Importer (768/2008/EC annex I, art. R4) „ „1. Importers shall place only compliant products on the Community market. 2. Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. […] Where an importer considers or has reason to believe that a product is not in conformity, he shall not place the product on the market until it has been brought into conformity. 5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements.”

14. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Importer (768/2008/EC annex I, art. R4) „ „6. […] importers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non- conforming products and product recalls, and shall keep distributors informed of such monitoring..” 7. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the Community harmonisation legislation applicable shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate.”

15. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Importer (768/2008/EC annex I, art. R4) „ „ 7. […] where the product presents a risk, importer shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken. 8. Importer shall keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. 9. Importer shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.”

16. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Distributor(768/2008/EC annex I, art. R5) Distributor (768/2008/EC annex I, art. R5) „1. When making a product available on the market distributors shall act with due care. […] 2. Before making a product available on the market distributors shall verify that the product bears the required conformity marking or markings. […] 3. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance.” The same obligation for cooperation with CA

17. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Supply chain Economic operators (768/2008/EC annex I, art. R7) „Economic operators shall, on request, identify the following to the market surveillance authorities (a) any economic operator who has supplied them with a product; (b) any economic operator to whom they have supplied a product.” In Poland period of time for keeping such a documentation at least 5 years from the day of delivery of the last device.

18. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl Usage - -User has to follow the instruction given by the manufacturer - -medical errors - -incidents - -usage errors - -All malfunction of the device shall be notified to the manufacturer / authorised representatives or to the CA (depends on national law) - -Manufacturer has to assess all signals from the market and: - could issue safety notice - could decide on withdrawal/ recall from the usage - could decide on doing nothing

19. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl COEN - -Member State created COEN Group (Compliance and Enforcement Group) to address all issues related to market surveillance activities - - COEN procedure - exchange of information between MSs - if „request for help” – investigation needed COEN 2 form

20. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl EUDAMED COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (Commission Decision 2010/227/EU) to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements

21. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl EUDAMED 01 May 2011 30 April 2012 entering data according to the Decision entering data existing before the Decision Actors ( MF/ AR); devices; certificates; clinical trials, incidents (NCAR)

22. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl

23. www.urpl.gov.pl

24. www.urpl.gov.pl Thank you very much for your attention joanna.kilkowska@urpl.gov.pl