The upcoming EU MDR. Gert Bos. - key changes overview. Executive director & Partner. ..the practical approach

Transcription

1 The upcoming EU MDR - key changes overview Gert Bos Executive director & Partner A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.

2 Highlights Objectives legal revision Highlights on legislative process 10 most critical changes Timelines moving forward Key impact Q&A Page 2 Copyright Qserve Group B.V.

3 Objectives in legislative reform Consistently high level of health & safety protection for EU citizens Free and fair trade of medical devices throughout the EU Adaption to significant technological & scientific progress in the sector over last 2 decades. Key elements: extending scope better supervision of notified bodies clear rights manufacturers/distributors stronger requirements medical evidence Page 3 Copyright Qserve Group B.V.

4 Objectives in legislative reform Consistently high level of health & safety protection for EU citizens Sufficient clinical data and performance evaluation results Free and fair trade of medical devices throughout the EU = Clinical Evidence Adaption to significant technological & scientific progress in the sector over last 2 decades. Page 4 Copyright Qserve Group B.V. State of the art

5 Four charges to improve ad interim Functioning notified bodies Market surveillance Coordination on vigilance Communication and transparency Page 5 Copyright Qserve Group B.V.

6 Living up to MDR/IVDR 2010 Guidance & interpretation Updated legislation Updated MEDDEV documents New harmonized standards State of the art 2013 Audits & supervision Joint inspection of NBs UAV system COEN coordination equirements & transparency MDR / IVDR Clinical trials Special NBs EUDAMED UDI Supply chain focus And more. Page 6 Copyright Qserve Group B.V.

7 Push on Notified Bodies Regulation: Re-designation of notified bodies Joint assessment teams Strong focus on qualification, independence, clinical evaluation Recommendation: Strict details on dossier assessment Strict details on audits Minimum frequency of unannounced visits Page 7 Copyright Qserve Group B.V.

8 Changes to Notified Bodies Expected 50% not re-designated or with significant scope change! Regulation on NB designation & recommendation on NB work Notified Body number dropped from 87 to 57; IVD-NB relatively stable at 22; expectations for next 6-12 months: more to go including some with IVD scope Some remain with reduced scope Notified bodies under pressure and scared Ongoing initial reviews stifle on growing requirements on clinical data and limits to equivalence use Line-extension reviews getting cumbersome Renewal halted; certificates not renewed in time Certificates suspended without clear warning NBs careful in accepting transfers Waiting lists generally increasing Page 8 Copyright Qserve Group B.V. MHRA

9 Elements of change new guidance MEDDEV rev 4 Clinical Evaluation Report for all classes of devices Benefit risk in intended use / target group Aligned with state of art in medical field concerned Inclusion of usability requirements Integrated in lifecycle management Clinical evaluation before and after clinical studies Expectation of larger patient numbers in studies Stronger focus on analysis and appraisal of data Qualification of evaluators Update (annually / 2 year / 5 year) Page 9 Copyright Qserve Group B.V.

10 Element of change shifting view on Own Brand Labeling Own Brand Labeler same requirements as OEM Access to full technical file, including e.g. sterilization validation at subcontractors of the OEM Access to OEM s PMS data Full audit and supply chain oversight Unannounced audits Page 10 Copyright Qserve Group B.V.

11 New MHRA guidance OBL => virtual manufacturer Page 11 Copyright Qserve Group B.V.

12 Intermezzo: the impact of a Brexit. Slow process; will take till Q Uncertainty on future is most critical impact Trade agreement? Accept new MDR / IVDR or separate legal framework? Continued notified body services? Continued authorized rep services? Etc. etc. Page 12 Copyright Qserve Group B.V.

13 Three key stakeholders Commission (2012) Parliament (2014) Council (2015) Page 13 Copyright Qserve Group B.V.

14 Trilogue Process Discussion method for negotiations between Council and EP to reach political agreement No formal rules, it does not exist in the procedures; there is an MoU between EP and Council Trilogues, but mainly negotiations between EP and Council; CIE facilitates. Page 14 Copyright Qserve Group B.V.

15 Finally MDR is published on May Page 15 Copyright Qserve Group B.V.

16 Finally MDR is published on May MDD 20 articles MDR 123 articles 60 pages 175 pages 12 annexes 16 annexes Directive Regulation Key elements of change Page 16 Copyright Qserve Group B.V.

17 Regulation EU 2017/ Whereas = Why 10 Chapters of 123 Articles = What XVI Annexes = How Chapter I Scope and Definitions Chapter II CE Marking, Economic Operators, Reprocessing Chapter III Identification and Traceability of Devices Chapter IV Notified Bodies Chapter V Classification and Conformity Assessment Chapter VI Clinical Evaluation and Investigation Chapter VII Vigilance and Market Surveillance Chapter VIII Cooperation between Member States Chapter IX Confidentiality, Data Protection, Funding, Penalties Chapter X Final Provisions Page 17 Copyright Qserve Group B.V.

18 Regulation EU 2017/ Whereas = Why 10 Chapters of 123 Articles = What XVI Annexes = How Annex I General safety and performance requirements Annex II Technical Documentation Annex III EU Declaration of Conformity Annex IV CE Marking of Conformity Annex V European UDI System Annex VI Requirements to be met by Notified Bodies Annex VII Classification Criteria Annex VIII Conformity Assessment QMS and Technical Documentation Annex IX Conformity Assessment Type Examination Annex X Conformity Assessment Product Conformity Verification Annex XI Procedure for Custom-made Devices Annex XII Certificates issued by a Notified Body Annex XIII Clinical Evaluation and Post-market clinical follow-up Annex XIV Clinical Investigations Annex XV Products without an intended medical purpose Annex XVI Correlation Table 90/385, 93/42 and Regulation Page 18 Copyright Qserve Group B.V.

19 Wider, clearer scope for EU legislation Products manufactured utilising non-viable human tissues or cells, or their derivatives, that have undergone substantial manipulation Reference human tissue donation and procurement legislation Certain implantable / invasive products without a medical purpose Clarification towards: products that contain or consist of viable biological substances food covered by Regulation (EC) No 178/2002 Page 19 Copyright Qserve Group B.V.

20 Common Specifications Extension of legal requirements Authored with little input from industry Technical and other specification Annex XV cosmetic implants Reprocessing of single use devices Clinical requirements and more Will gradually replace MEDDEVs and (selected) Standards Page 20 Copyright Qserve Group B.V.

21 Stronger supervision of notified bodies System moves from New Approach to New Legal Framework Stronger supervision on Notified Bodies Continuation of joint assessment; manual transcribed into NB annex Focused clinical scrutiny mechanism on high risk devices Because of that: Stronger supervision by Notified Bodies Page 21 Copyright Qserve Group B.V.

22 More powers for assessment Thorough testing and regular checks on manufacturers Much stricter acceptance criteria on clinical data and equivalence Unannounced factory inspections, including supply chain Rotation of notified body staff involved in assessment Adoption of common (technical) specifications Page 22 Copyright Qserve Group B.V.

23 Clearer rights & responsibilities Clearer responsibilities for manufacturers, importers and distributors Also applicable to diagnostic services and internet sales Establishing a qualified person in manufacturer or authorized rep. Relabeling and repackaging clarified Liability detailed (manufacturer and authorized rep.) Page 23 Copyright Qserve Group B.V.

24 Obligations Importer & Distributor Verify device is CE marked & with Declaration of Conformity & AR designated Verify appropriate labelling & IFU, including assignment UDI & registration EUDAMED Appropriate storage or transport conditions Inform authority on (suspected) non-compliance Keep a register of complaints, non-conforming products, product recalls and withdrawals Provide other economic operators with information to investigate complaints Immediately forward information on complaints to manufacturer & AR Keep a copy of the declaration of conformity and a copy of the certificate Importers shall indicate name & address on the device, its packaging or in a accompanying document Page 24 Copyright Qserve Group B.V.

25 Liability Proportionate to the risk class, type of device and the size of the enterprise, manufacturers shall have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. Liability extended beyond manufacturer and importer to authorized representative Liability for notified bodies Liability for sponsor in clinical trial Page 25 Copyright Qserve Group B.V.

26 Reprocessing of Single Use Devices (Recital 38) Reprocessing of SUDs only where permitted by national law, and in respect of requirements laid down in this Regulation. Reprocessor should be considered the manufacturer of the device. Member States may decide that reprocessing and re-use of SUDs within a health institution may vary from the obligations of the manufacturer described in this Regulation. In principle this is only permitted when adequate common specifications are in place and if appropriate national regulations exist and are applied in the reprocessing of these devices which ensure AT LEAST THE SAME LEVEL OF SECURITY as in case of the corresponding initial SUDs. This also applies if the reprocessing is carried out by an external reprocessor on behalf of a health institution. Page 26 Copyright Qserve Group B.V.

27 Extended Eudamed database Registration of devices and economic operators Comprehensive information on products available on the EU market Non-confidential data will be publicly available Public summary of safety and performance Page 27 Copyright Qserve Group B.V.

28 Better traceability Better traceability of medical devices throughout the supply chain Swift and effective response to safety problems (e.g. recalls) phased introduction of Unique Device Identification (UDI) UDI on label, higher packaging, UDI on Declaration of Conformity; UDI included in implant card; UDI central in EUDAMED database Page 28 Copyright Qserve Group B.V.

29 UDI UDI on label, higher packaging, DoC; included in implant card, stored by health institutes; UDI in database before placing products on the market UDI on NB certificates IIb implants and III UDI for now allowed under: GSI AISBL HIBCC ICCBBA UDI application: 1 yr: implantables and class III 3 yr: class IIa and Iib 5 yr: rest UDI basis for vigilance reporting Page 29 Copyright Qserve Group B.V.

30 Stricter requirements for clinical evidence Stricter requirements for clinical evidence to support assessments Interventional clinical performance studies Studies with invasive procedures or other risks Sponsor introduced Database for clinical studies Ethical consent detailed Continuous performance evaluation integrated in PMS Page 30 Copyright Qserve Group B.V.

31 Hazardous substances CMR substances / endocrine disruptors > 0.1% for body contacting devices and devices in contact with medicines need justification Justification details extensified in ER Irrespective of existing applicable environmental legislation (REACH) Guideline on phthalates Guideline on CMR / endocrine disruptors Page 31 Copyright Qserve Group B.V.

32 Updated classification rules Keeps four risk classes; AIMD integrated Reclassifications: AIMD and accessories => III Selected orthopaedic implants => III Deliberate Nano => III Critical care active devices => III Ingested, inhaled or administered rectally or vaginally and absorbed by or dispersed in the human body Page 32 Copyright Qserve Group B.V.

33 Better coordination Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support Clinical evaluation / scrutiny Market surveillance / vigilance Governance system MedDev Coordination Group (MDCG) Encourage device registers Page 33 Copyright Qserve Group B.V.

34 Consultations An.IX-5.2 Pharmaceuticals EMA for biotech, recombinant etc. and MS for any others 210 days after receipt of valid documentation: opinion delivered No way to overrule negative opinion; any change relating to pharmaceutical: 60 day review An.IX-5.3 Animal tissue/cells, TSE susceptible (EC 722/2012) Consultation as per current TSE Regulation (EDQM 4 wks, no EDQM 12 wks Page 34 Copyright Qserve Group B.V. An.IX-5.3 Human tissue/cells Consultation with human tissues and cells competent authority 120 days after receipt of valid documentation: opinion delivered No way to overrule negative opinion, same change control as pharmaceuticals An.IX-5.4 Substances absorbable as per intended purpose EMA or MS drug authority, 150 days

35 Scrutiny on implantable class III devices (An.IX-5.1) NB clinical evaluation assessment report on risk-benefit, consistency with intended purpose and PMCF plan NB report, clinical evaluation docs to Commission, forwarding to expert panel Optional presentation of NB to expert panel Page 35 Copyright Qserve Group B.V. In case no opinion will be delivered: 15 days, with motivation of decision; NB proceeds Opinion from expert panel in 60 days; NB proceeds If no opinion in 60 days. NB may proceed Restriction of purpose to numbers or groups of patients Limitation to validity of certificate Demand for specific PMCF studies Adaptation of Instruction for use Other restrictions

36 Procedure packs art. 22 So what is different?? Mix with IVD; mix with non-devices when justified Statement on mutual compatibility, packaging with relevant information, appropriate methods of internal monitoring, verification and validation Sterilization subject to NB conformity assessment No additional CE mark, but room for tradename, trademark Page 36 Copyright Qserve Group B.V.

37 Procedure packs art. 52 where the system or procedure pack incorporate devices which do not bear the CE marking where the chosen combination of devices is not compatible in view of their original intended purpose where the sterilization has not been carried out in accordance with the manufacturer's instructions => procedure pack shall be treated as a device in its own right; subject to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers. Page 37 Copyright Qserve Group B.V.

38 Key Impact Private label route to fund initial developments blocked Clinical data requirement pre-market strongly enhanced higher upfront investments Regulatory requirement much more demanding - higher upfront investments Portfolio rationalization strategies initiated New strategies to develop (proof of) concept instead of direct sales Ongoing mergers and acquisitions at the top Many SME will go out of business or will change company strategy Page 38 Copyright Qserve Group B.V.

39 What to expect? NB s faster to implement changes NB s implement before end of transition NB s too busy for all the work Increasing uncertainty on path forward, existence of NB, availability of services Expect bars to be raised and issuance of certificates to be a timeconsuming effort Page 39 Copyright Qserve Group B.V.

40 Resourcing at NBs, authorities, commission Some NB fully ready, double procedures, double the staff Authorities typically at 0-growth policy EUDAMED specs being set, expect 3 years development UDI to be specified in details, expect 3 years development Harmonization of standards, expect 2-3 years development Hospitals not required to use UDI CS: priority list in place: UDI, EUDAMED, NBs, annex XV Page 40 Copyright Qserve Group B.V.

41 Thank you for your attention Gert Bos Executive director & Partner A global leading medical device consultancy group Page 41 Copyright Qserve Group B.V. Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.