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Easy medical devices podcast self tests ivdr

Backup slides presentation about IVD self tests regulation under the In Vitro Diagnostics Regulation IVDR, applicable as of end May 2022

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Easy medical devices podcast self tests ivdr

  1. 1. IVDR COMPLIANCE & IMPLICATIONS FOR IVDD SELF- TESTS Easy Medical Device Podcast Erik Vollebregt www.axonadvocaten.nl
  2. 2. Overview of changes • Transitional regime • New definitions • New marketing/labeling/advertising rules • New conformity assessment procedure • New classification mechanism • New design requirements and risk management • New labeling and IFU requirements • New Eudamed registration requirements • New clinical performance studies requirements
  3. 3. IVDR Transition (Article 110) 05 May 2017 Adoption of IVDR Entry in to Force 25 May 2017 NBs designation under IVDR Date of Application 26 May 2022 IVDD certificate validity (2 years ) IVDD certificates can be issued/re-issued/renewed IVDR certificates Transition period 5 years No more « making available or putting into service » of devices covered by IVDD certificates IVDD certificates void 27 May 2024 27 May 2025 NBs can apply for designation 26 Nov 2017
  4. 4. No grandfathering and firm implementation deadlines • All devices on the market are phased into the new system by the end of transitional period • This means that you have to do a new conformity assessment under the new rules for all devices currently on the market or remove the product from the market • If you don’t have a new CE under IVDR, you cannot place new product on the market after transition period
  5. 5. Definitions We have a definition now: • “‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;” (article 2 (5) IVDR) • “including devices used for testing services offered to lay persons by means of information society services” – e.g. self-swabbing plus specimen receptacle devices for a COVID 19 test sold via the internet • Can include MDSW (Medical Device Software, see MDCG 2019- 11, fn 18), as long as there is a sample involved
  6. 6. Definitions • Borderline with ‘device for near-patient testing’ (see definition in article 2 (6) IVDR) - can be very similar but near-patient testing IVDs are never intended for self-testing • Especially in COVID-19 times authorities are very vigilant for mixing these up • Self testing is always for lay-persons
  7. 7. Scope • IVDR does not apply to invasive sampling self-tests applied directly to the body for obtaining a sample (article 1 (3) (b) IVDR • Self testing IVDs incorporating an integrated medical device are in scope of MDR, but IVDR applies to IVDR part (article 1 (4) IVDR)
  8. 8. Conformity assessment and classification Article 48 IVDR possible assessment routes • Class D (article 48 (3)) – possible depending on intended use • Class C (article 48 (7) / rule 4 Annex VIII - default class for self-testing) • But: Class B (article 48 (9) / rule 4 Annex VIII – pregnancy, fertility testing, determining cholesterol level and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine) • Annex IX section 5.1 – special procedure for class B, C and D self- testing devices – technical documentation assessment by NB • Specific approval procedure for any change that can affect safety, performance or conditions prescribed for use (Annex IX, section 5.1 (f))
  9. 9. Conformity assessment and classification • Implementing rules • If SaMD involved that drives or influences the use of a device (e.g. connected specimen collection device) then software is same risk class (Annex VIII, 1.4) • If several rules apply (whether or not as a result of multiple intended purposes), highest classification must be used (Annex VIII, 1.8 / 1.9)
  10. 10. Conformity assessment • Annex X type testing possible to a conformity assessment route • Application includes • “test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing” • “data showing the suitability of the device in relation to its intended purpose for self-testing”
  11. 11. GSPRs specific to self-testing devices Annex I 9.4 (a) - performance and characteristics to be specifically checked for self-testing devices use under normal conditions for performance obtained by lay persons Annex I, 19 - protection against risks posed by self testing devices by means of specific risk management measures in design and labeling: • 19.1 design, manufacture and IFU must be such that device produces easy to interpret and non-misleading information • 19.2 design and manufacture for lay person usability and accuracy when used by lay persons; usability design to reduce user error • 19.3 device must include a procedure by which the intended user: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and (b) be warned if the device has failed to provide a valid result. • PLUS: generally increased and more specific risk management
  12. 12. GSPRs • No standards yet for self-testing devices under IVDR, see: https://medicaldeviceslegal.com/2020/ 06/20/standardisation-request-for- mdr-and-ivdr-refused-now-what/ • Soooo • EN 13532:2002 • EN ISO 15197:2015 • EN ISO 18113-4:2011 • Not harmonised and you have to define state of art yourself with rationale why an unharmonised standard is still state of art
  13. 13. Labeling and IFU • Intended user determines medium, format, content, legibility and location of label and IFU (Annex I, section 20 (a)) • Article 10 (10) 2nd IVDR: information for self testing devices must be • easily understandable; and • provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.
  14. 14. Labeling and IFU • Special labeling considerations • eIFU possible? – Annex I, section 20.1 • May also be provided on MFR website but for self testing IVDs IFU must still be provided on paper (Annex I section 20.1 (f)) • No single IFU for multiple IVDs packs – Annex I, section 20.1 (e)
  15. 15. Labeling and IFU • 20.2 (q) - indication of self testing device on the label • 20.2 (r) - explicit exclusion on label for rapid assays not intended as self test • 20.2 (u) - particulars on label / intended purpose • (i) the type of specimen(s) required to perform the test (e.g. blood, urine or saliva); • (ii) the need for additional materials for the test to function properly; • (iii) contact details for further advice and assistance. • The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer (that would also likely be an article 7 IVDR violation)
  16. 16. Labeling and IFU 20.4.2 contains a considerable list of IFU principles that must be complied with in addition to general IFU elements and principles (all to be described in accordance with article 10 (10) 2nd IVDR: easily understandable): a) details of procedure, collection, preparation and interpretation of results b) permitted omissions of particulars c) intended purpose provides sufficient information to enable the user to understand the medical context and interpret the results correctly d) results are expressed and presented in a way that is readily understood by the intended user e) information on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result, and on any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication;
  17. 17. Labeling and IFU f) a statement clearly directing that the user should not take any decision of medical relevance without first consulting the right persons/sources g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so
  18. 18. Eudamed device registration • Information relating to the device to be provided to Eudamed in accordance with article 26 (3) IVDR • “indication as to whether the device is intended for self-testing or near- patient testing” - Annex VI Part A section 2.14
  19. 19. Clinical performance study requirements • Performance evaluation covers self-testing aspects in clinical performance study plan (2.3.2) (c): • CPSP – includes information, in the case of a self testing device, on number and location of self testing lay persons involved
  20. 20. PMS and PMPF • Don’t forget to make this relevant for the user base of self-testing lay persons • Article 78 IVDR: PMS system of MFR is life cycle activity – monitor performance in real world over time • Article 79 and Annex III PMS plan • Annex III and Annex XIII Part B: PMPF plan (continuous update of performance evaluation) • How will MFR obtain PMPF information from the market of self testing lay persons? • Class C (default for self-testing): article 81 requires PSUR at least annually and submission of PSUR to NB
  21. 21. Claims for self-testing devices • Article 7 IVDR prohibition of misleading patient – end user ties back into labeling and IFU and many other processes (MDR example below)
  22. 22. Marketing of self-testing devices more tricky
  23. 23. Thanks for your attention! Erik Vollebregt Axon Lawyers Piet Heinkade 183 1019 HC Amsterdam T +31 88 650 6500 M +31 6 47 180 683 E erik.vollebregt@axonlawyers.com @meddevlegal B http://medicaldeviceslegal.com READ MY BLOG: http://medicaldeviceslegal.com