European Regulations of Medical Devices and In-vitro Diagnostic Medical Devices. The Notified Body Point of View

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1 European Regulations of Medical Devices and In-vitro Diagnostic Medical Devices The Notified Body Point of View Dr.-Ing. Christian Zietsch Berlin

2 Preliminary notes All information given, are given with reservations! At the moment the future is not 100% clear. The basic concept is fixed, but the detailed implementation is partly unknown (e.g. Common Specifications). mdc medical device certification GmbH Folie 2

3 Table of Content Introduction (short) Challenges for the Notified Bodies and Economic Operators Important Transition Provisions MDR Consequences from the Transition Provisions IVDR - Timelines Notified Bodies: New Tasks and Functions Examples Audits Recommendations Conclusions mdc medical device certification GmbH Folie 3

4 Introduction As EU-Regulations the Regulation on Medical Devices and the Regulation on In Vitro Diagnostic Medical Devices are directly applicable without transformation into national laws! The regulations have been already entered set in force, but the date of application is later and there are various transition periods. Some parts may be already used before the day of application. National medical device laws must be completely revised and adapted (no contradictions to regulations). mdc medical device certification GmbH Folie 4

5 Introduction Motto: Go back to START New notifications of the Notified Bodies New certifications of the manufacturers New registrations of the products There is no grandfathering! mdc medical device certification GmbH Folie 5

6 Challenges for the Notified Bodies & Economic Operators Complete notification is required, for both MDR and IVDR (new requirements are much higher compared to notifications under MDD / IVDD) Expected duration at least 1 year after (earliest date of application for notification under MDR/IVDR) Notified Bodies will be notified earliest end of 2018 / beginning of 2019 and then capable of acting It can not be predicted how many NB will be notified and with which scopes The authority responsible for notified bodies will review an appropriate number of NB assessments of manufacturers technical documentation (as part of its ongoing monitoring of NB) mdc medical device certification GmbH Folie 6

7 Challenges for the Notified Bodies & Economic Operators Systems old and new must exist in parallel at the NB and manufactures Work load of NB per manufacturer will increase considerably (app. factor 2 to 3) During the very limited transition periods a high quantity of recertifications according to the Directives as well as initial certifications according to the Regulations will be demanded Although the personnel resources of the NB have been expanded extreme capacity shortages are expected mdc medical device certification GmbH Folie 7

8 Important Transition Provisions (MDR - Article ) Publication Entry into force Start of application period for Notified Bodies Date of application Expiry of notifications under Directive 93/42/EEC End of issuing certificates according to Directive 93/42/EEC For all devices without a certificate according to Directive 93/42/EEC, for all new devices and for all old devices with modified design / intended use the MDR is mandatory mdc medical device certification GmbH Folie 8

9 Important Transition Provisions (MDR - Article ) Last expiry date for certificates and last date for placing products on the market under Directive 93/42/EEC End of distribution and putting into service of products placed on the market under Directive 93/42/EEC Short: three years transition period ( ) mdc medical device certification GmbH Folie 9

10 Consequences from the Transition Provisions All products, which are covered by a certificate (!) under Directive 93/42/EEC and the design and intended use remains without changes, may be placed on the market until 26 May For class I products (non-sterile, no measuring function) this is not the case. They have to fulfil the MDR by 26 May In order to receive a certificate according to Directive 93/42/EEC valid until 26 May 2024, the initial or renewal certification needs to be fully completed and issued between 26 May 2019 and 26 May Due to the capacities at the Notified Bodies there will be deadlines regarding inquiries (duly filled questionnaires including all attachments), applications and complete documents (quality documents and technical documentation). mdc medical device certification GmbH Folie 10

11 IVDR - Timelines Regulation on IVD, 2017/746 coming in force: Applications for Notified Bodies possible from Assessment of applications (expected: years) Notification to Commission??, Start of conformity assessments acc. Regulation 2017/746 Mandatory application of Regulation 2017/746: (Exceptions see articles 110, 113) EC-Certificates acc. 98/79/EC become void: Short: five years transition period ( ) mdc medical device certification Folie 11

12 Notified Bodies: New Tasks and Functions The Essential Requirements acc. MDD/IVDD are widely expanded to General Safety and Performance Requirements acc. MDR, IVDR Much higher Requirements for Technical Documentations (e.g. MDR Annex II, III) Much higher Requirements for Clinical Evaluation and Post Market Clinical Follow-up etc. (MEDDEV 2.7/1 Rev. 4, MDR Annex XIV) and New Consultation Procedures for class III and certain active class IIb devices Numerous additional reports that need to be updated on a regularly basis e.g. PMCF, PMS, PSUR (periodic safety update report), Summary of safety and clinical performance, Trend reporting Reclassifications (higher risk class) of certain Medical Devices and IVD mdc medical device certification GmbH Folie 12

13 New Consultation Procedures New Consultation Procedures for implantable class III devices and active class IIb devices, which administer or remove pharm. products The NB issues a Clinical Assessment Evaluation Report (CAER) on the clinical evaluation and sends it together with the clinical evaluation to the European Commission. The report and the documents are forwarded to an experts committee. The expert committee will decide within 21 days whether or not an expert report regarding the CAER is drawn up. If yes, the expert report is issued within 60 days. The Notified Body takes the expert report into consideration for the decision (In case after 60 days no feedback is available, the Notified Body can continue the conformity assessment.) mdc medical device certification GmbH Folie 13

14 Notified Bodies: New Tasks and Functions For class I reusable surgical instruments (Ir) the following aspects of reprocessing need to be checked by the Notified Body: cleaning disinfection sterilisation maintenance functional testing instructions for use The assessment will be performed within a certification of the quality system but will also require parts of the technical documentation. mdc medical device certification GmbH Folie 14

15 Notified Bodies: New Tasks and Functions Common Specifications (CS) will be developed under the MDR/IVDR and published as EU Commission Decisions The Common Specifications can include technical requirements, documentation needs regarding technical documentation, clinical evaluation, performance evaluation and post market surveillance as well as PMCF requirements Common Specifications have a higher status than harmonized standards and are practically mandatory mdc medical device certification GmbH Folie 15

16 Notified Bodies: New Tasks and Functions Approx % of other IVD (acc. IVDD) will require Notified Body activity and need certification acc. to IVDR New Economic Operators Importers and distributors, which re-pack or re-label products have to fulfil defined requirements including the obligation for certification by a Notified Body EUDAMED and UDI mdc medical device certification GmbH Folie 16

17 Economic Operators Manufacturer Control Information Control Importer Distributor Information Control Information Information Information Authorised Representative Broad tasks and cooperation: Traceability UDI Product registration Complaints Adverse events Corrective actions mdc medical device certification GmbH Folie 17

18 EUDAMED Modular European Database mdc medical device certification GmbH Folie 18 Lübeck Summer Academy on Medical Technology; July 4, 2017, Dr. Almut Fröhlich, Federal Ministry of Health

19 Audits The first audit according to MDR / IVDR will be an very comprehensive initial audit. The basis so far used for audit time calculation may not be sufficient for the future. Surveillance audits according to MDR / IVDR may even in small companies not possible within one day. Surveillance audits have to be performed at least every 12 months. Suppliers / subcontractors will be more involved in audits. More focus will be taken on PMS, PMCF, Vigilance. mdc medical device certification GmbH Folie 19

20 Recommendations Due to extensive assessments of technical documentations etc. the full transition from 93/42/EEC, 90/385/EC and 98/79/EC to MDR / IVDR may not be possible on the same date for all devices of a manufacturer. Some manufacturers need to be prepared to run the old and new system in parallel. Start the transition to MDR / IVDR a.s.a.p. (optimal already started), contact your NB for coordination, time line etc.. Thing twice about changing the NB now or within the next years. Expect higher costs and longer processing time, due to the increasing amount of work (Economic Operators and NB). mdc medical device certification GmbH Folie 20

21 Recommendations If you need additional employees, start recruiting now. Check the information, given by Notified Bodies, consultants etc., on a regular basis keep updated. There are various seminars with respect to the MDR and IVDR you should participate, for example: - mdc seminar Tech. Documentation acc. to MDR , Berlin - mdc seminar Clinical Evaluation acc. to MEDDEV 2.7/1 Rev. 4 & MDR , Berlin - mdc seminar MDR basics , Berlin - mdc seminar IVDR basics , Berlin mdc medical device certification GmbH Folie 21

22 Conclusions All involved parties (manufacturers, Notified Bodies, Competent Authorities ) expect a high workload. A binding conformity assessment by the Notified Body will by possible only after notification. Due to the fact that the transition period under MDR is extremely short and that under the IVDR a lot of devices will now need certification, the time needs to used for preparation. Manufacturers can not wait for the Notified Body. The transition periods have to be also used for timely (re-)certification according to the old Directives. Priority for the Regulations should be for the devices, which so far are not covered by a certificate according to the Directives. A good (!) compliance with the current Directives is a important basis for the Regulations. mdc medical device certification GmbH Folie 22

23 Thank you for your attention! Questions? mdc medical device certification GmbH Folie 23

24 mdc medical device certification GmbH Kriegerstraße Stuttgart Telefon: +49 (0) 7 11 / Telefax: +49 (0) 7 11 / mdc@mdc-ce.de mdc medical device certification GmbH Niederlassung Berlin Albert-Einstein-Str Berlin Telefon: +49 (0) 30 / Telefax: +49 (0) 30 / mdc@mdc-ce.de mdc medical device certification GmbH Zweigniederlassung austria Wienerbergstraße 11 / A Wien, Österreich Telefon: +43 (1) / Telefax: +43 (1) / mdc@mdc-ce.at mdc medical device certification GmbH Folie 24