IVDR Update Get Ready for the Ride. MassMEDIC World MedTech Regulatory Update

Transcription

1 IVDR Update Get Ready for the Ride MassMEDIC World MedTech Regulatory Update Carol C. Ryerson, Ph.D. Sr. Principal Advisor, Regulatory Affairs Jun 8, 2017

2 Agenda Overview of the IVDR (EU) 2017/746 Business Impact Clinical evidence requirements Technical documentation requirements What else? 2

3 IVDR Biggest Challenges 1. Risk- based classification for all IVDs 2. Changes in conformity assessment routes; more than 80% of IVDs will now require notified body review of Technical Documentation 3. Significantly more clinical evidence is required 4. IVD definition has expanded, and now includes nutrigenetic tests and lifestyle tests 3

4 IVDR Classification Class D Class C Class B Class A High public health risk, high personal risk HIV 1/2 Hepatitis B virus Hepatitis C virus HTLV I/II Blood grouping ABO, Rhesus (including RHW1), Kell, Kidd and Duffy systems CHAGAS Syphilis screening High personal risk, moderate to low public health risk Syphilis diagnosis Neonatal screening for metabolic disorders Rubella Cancer markers Genetic tests Companion diagnostics Blood glucose meters/ strips Self tests Moderate to low personal risk, low public health risk Thyroid function Infertility assays Clinical chemistry Self-test devices listed: not Class C Note: Near patient tests are classified in their own right Low personal risk, low public health risk Accessories Wash buffers Specimen receptacles Instruments Culture media 4

5 Conformity Assessment 5

6 IVDR Timeline IVDR May 5, years 2 years Grace period For existing IVDD CE May 2024 May 2022 Full compliance No new IVDD CE may be issued No changes IVDR elements apply 5 years 6 May 2017 IVDD Continues May 2022 IVDD expires

7 IVD Business Impact Will the EU still be the location for initial new product launches? Will some IVD products be pulled off the market? How will medical practice and healthcare in the EU change? What will the increase in cost be to keep products on the market in the EU? When is the best time to switch from IVDD to IVDR? 7

8 IVD Business Impact Management Regulatory Authorised Rep edc tools EU Market Quality Distributors/ Importers Supply Chain 8

9 Gap Assessment 1. Product type & Classification 2. Which conformity assessment route should we follow? 3. Data what constitutes clinical evidence? 4. Technical Documentation IVDR version 5. Quality Agreements Authorised Rep, Distributors, Importers 6. Resources 9

10 Points to Consider What products meet all requirements and can be certified to IVDR today? What products require additional work to comply with IVDR and how long will that take? What products will be taken off the market in the EU? When will IVDR be implemented for new products? When will your notified body be accredited for IVDs under the IVDR? 10

11 Performance Evaluation Incorporates all 3 elements = clinical evidence Analytical Performance Clinical Performance Scientific Validity 11

12 IVDR Definitions Scientific Validity association of an analyte with a clinical condition or physiological state New for IVDR: Scientific/ professional publications or clinical studies Analytical Performance ability of a device to correctly detect or measure a particular analyte Performance requirements similar to IVDD Clinical Performance ability of a device to yield results that are correlated with a particular clinical condition or physiological or pathological process or state in accordance with target population and intended user IVDR includes specific parameters to be included in studies 12

13 Scientific Validity 1. Scientific validity shall be based on one or more of the following: Relevant information on scientific validity for other devices measuring the same marker or analyte Scientific (peer-reviewed) literature Consensus expert opinion from relevant professional associations Proof of concept studies Clinical performance studies 2. For companion dx and novel IVDs proof of concept studies will be required 13

14 Clinical Performance Clinical performance of a device shall be based on one or more of the following: Clinical performance studies Scientific peer-reviewed literature Published experience gained by routine diagnostic testing 14

15 Analytical Performance For novel markers: Where certified reference materials are not available to define trueness Compare to well-documented methods, or Compare to the composite reference standard In the absence of suitable reference materials a study comparing performance of the novel device to the current clinical standard practice is required 15

16 Performance Evaluation Plan Stage 1 Identify clinical evidence from: Literature search and/or Clinical experience and/or Clinical performance studies and Analytical performance studies Stage 2 Appraisal of individual data sets: Suitability Contribution of results to demonstration of performance and safety Generate new or additional analytical/ clinical data No Is clinical evidence sufficient to be able to declare conformity with relevant ERs? Stage 3 Analysis of relevant data: Strength of overall evidence Conclusion about performance and safety 16 Yes Produce Performance Report

17 Performance Evaluation Report The PER Report shall include: Nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated Clinical evidence as the acceptable performance against the state of the art in medicine Any new conclusions derived from post-market performance follow-up (PMPF) reports Updated throughout the product lifecycle for all devices and at least annually for Class C and D 17

18 Technical Documentation Annex II and III list in detail the required content; this section is new and was not part of the IVDD Living documents; kept up to date throughout the life cycle of the device Updated at least annually for Class C and D devices Cover all steps of the product s lifecycle from design to manufacture to discontinuance 18

19 TD as living documentation Quality Records DHF DMR Risk File Labeling Complaints Vigilance subset Searchable links Technical Documentation Device Description/ scope GSP Checklist Risk Benefit Summary Product V & V PER PMS and PMPF Plans Dossier Submission Subset; Keep copy 19

20 What else? New ERs; now called General Safety & Performance requirements Requirements for conducting clinical studies with increased risk e.g. interventional use of IVD Person responsible for regulatory compliance University degree + 1 y IVD experience or 4 y IVD experience LDT definition clarified, and specifies devices for use only within health institutions UDI and device registration Increased obligations for Authorised Representatives, importers, distributors Vigilance Reference laboratories for class D device testing Increased scrutiny and requirements for notified bodies 20

21 Be organized Think GLOBAL 21

22 Questions Carol C. Ryerson, Ph.D. Sr. Principal Advisor, Regulatory Affairs Regulatory and Clinical Research Institute, Inc. (RCRI) Based in Boston area Direct: