Self-Care Medical Devices Framework. Dr. Simone Breitkopf Head HEOR, Governmental and Public Affairs

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1 Self-Care Medical Devices Framework Dr. Simone Breitkopf Head HEOR, Governmental and Public Affairs

2 Disclaimer The view and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not necessarily be attributed to Alcon/Novartis These slides are intended for educational purposes only and for the personal use of the audience. These slides are not intended for wider distribution outside the intended purpose without speaker approval

3 Self-Care Medical Devices Framework Current status of the new EU legislations (Medical Device Regulation, MDR, ISO13485, upcoming EU Legislation on Health Technology Assessment, HTA) Main general topics of the Medical Device Regulation, MDR Borderline Medical Devices Medicinal Products Impact on Substance-based Medical Devices from MDR Conclusions 3 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

4 Changing Regulatory Framework for Medical Devices in Europe EU Medical Device Regulation Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/ % 15% 10% Procurement Reimbursement via prescription Over the counter 5% HTA of Innovations* EU HTA Initiative Public Consultation started Oct 2016, 5 Options proposed by EC for future EU Cooperation on HTA including possible legislation for all health technologies (pharma and devices) *Source Eucomed EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

5 EU Medical Device Regulation Medical Devices Directive 93/42/EC, MDD Extended by Directive 2000/70/EC (stable derivatives of human blood/plasma) Extended by Directive 2001/104/EC (additional categories of blood products) Active Implantable Medical Devices Directive 90/385/EC, AIMD MDR Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices); In vitro Diagnostic Devices Directive 98/79/EC IVDR Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices). 5 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

6 EU Medical Device Regulation - Timeline First proposal in 2012 Text agreed by the EP and the Council in June 2016 Final formal adoption is expected both on the Council and the Parliament sides during first semester 2017 (March 17th) Transition period 2017 Adoption Formal Publication of MDR 3 Years Transition CE certificates granted for max 5 years under MDD 2020 Application Entry into Force of MDR 6 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

7 ISO 13485:2016 Requirements for Quality Management Systems specifically for Medical Device Companies ISO 13485:2016 is an update to the previous versions 13485:2003/2012 For companies currently certified to ISO 13485, there is a 3-year adoption period up to Nov Until March 2019 current ISO certificates has to be updated to the new version Main topic is risk management. QMS to incorporate risk-based decision making processes Medical Device File (product families possible) Facilitate adoption to FDA requirements, 21 CFR part Formal Publication of ISO 13485: Years Adoption to new requirements March 2019 Deadline for update of current certificates 7 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

8 Health Technology Assessment Scope of EU HTA Collaboration HTA = assessing value of a health technology compared to current standard of care, 2 step approach: clinical assessment economic evaluation Results of HTA support decision making bodies in deciding on budgets, prioritisation, pricing and reimbursement European Commission considering a compulsory European HTA for all health technologies incl. pharma and devices for the period beyond 2020 Current focus on high risk devices uses synergies with new requirements for same products from upcoming EU Medical Device Regulation, MDR, Binding definition needed for products eligible for HTA, to improve predictability for industry Lobbying appreciated to exclude substance based medical devices, reclassified as class III, class IIb 8 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

9 Health Technology Assessment Future of EU HTA Collaboration 5 options proposed by European Commission for European HTA Collaboration for the period beyond 2020 for both pharmaceuticals and medical devices: Option 1 Option 2 Option 3 Option 4 Option 5 Status quo voluntary cooperation until 2020 Long-term voluntary cooperation (beyond 2020) Cooperation through the collection, sharing and use of common tools and data Cooperation on production of joint REA reports Cooperation on production of joint Full HTA reports No legislation necessary EU Legislation necessary 9 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

10 Timeline on potential EU HTA-Legislation Sept 14th 2016 Inception Impact Assessment 5 Options published Oct 21 st Forum European cooperation on HTA: what s next? Brussels Oct 21st Jan 13st Public Consultation On EU HTA Questionnaire Up to Jan 22nd Stakeholder Consultation/ Questionnaire on Impact of Policy Options End 2017 EC Impact Assessment Report End 2018 EC First draft Legislation Input by Industry Lobbying 3rd party engagement EC: "The Commission has supported voluntary cooperation on HTA for more than 20 years, and through several HTA Joint Actions, we have built a solid knowledge based on methodologies and information exchange. Now it is time to take the next step: to build a permanent, sustainable mechanism for EU cooperation on HTA so that all Member States can benefit from the added value created by pooling resources, exchanging expertise and avoiding duplication in the assessment of the same product or intervention." 10 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

11 EU Medical Device Regulation - MDR Objectives This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users and taking into account the small and medium sized- enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices should be introduced, to improve health and safety 11 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

12 MDR Main Topics Classification changes Notified Bodies Responsible Person Quality Management System There are still four risk-based classes for MDs and AIMDs Class I, IIa, IIb and III most substance-based MDs which have currently been classified as self-certified would be classified as higher risk, IIa, IIb, III. NBs will be designated as a Notified Body under the new MDR by their Competent Authority. Many more manufacturers will have to engage Notified Bodies as part of their conformity assessment procedures. MDs manufacturers will have to appoint Persons Responsible for Regulatory Compliance to handle batch releases, technical documentation and post-market surveillance and vigilance efforts. Requirements for receiving certification under MDR mainly acc new ISO 13485:2016 Clinical Evidence Requirements Post-market Surveillance PMS Class III scrutiny Unique Device Identification (UDI) EUDAMED MDCGs, Medical Device Coordination Group 12 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon Concerning Class III and implantable devices. More extensive requirements for clinical data, equivalence claims, Scope extended to efficacy incl patient relevant benefit (=> already preparing for HTA) Clinical Evaluation has to be updated periodically based on Post Market Surveillance (PMS) data. PMS data which the Periodic safety update report (PSUR) is based on should be used to update the CER. SummaryofSafetyand Performance requirements (SSP) Notified Bodies will have to inform relevant Competent Authorities about all new CE Mark certificates issued to Class D IVDs; Competent Authorities may at their discretion appoint experts to evaluate clinical data for such devices. Devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient, should significantly enhance the effectiveness of post-market safety of medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities European Database for Medical Devices, since 2011, access to be extended to much more stakeholders incl manufacturers, testing period will start soon, operational by early 2019, fully functional by end composed of persons/experts designated by Member States

13 MDR Transition Period Certificates issued under MDD and AIMD before MDR adoption have full five year validity (e.g. March 2017 to 2022) Batch verification certificates issued before MDR adoption (planned for March 2017) are valid until two years after MDR application Certificates to the MDD or AIMD issued after MDR adoption have full five year validity, unless that exceeds four years after the date of application Certificates to the MDR can be issued from a designated Notified Body from MDR adoption, and have certificate validity of five years All Notified Bodies can start working under the new Regulation once they have been designated as a Notified Body under the new MDR by their Competent Authority. 13 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

14 MDR - Scope of Products - What s New? 1. Extended scope due to combination of both Medical Devices, acc Directive 93/42/EC and Active Implantable Medical Devices acc Directive 90/385/EC 2. Regulation will be extended to groups of products without an intended medical purpose (Ch. I, Art. 1a). These products, which are listed in Annex XV, are similar to medical devices in terms of their characteristics and risks. Annex XV: Examples are contact lenses, facial dermal fillers, equipment for liposuction, lasers for skin resurfacing or hair removal, and equipment for electromagnetic brain stimulation (mainly aesthetic or other non-medical purpose) 1aa. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose. 14 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

15 MDR - Scope of Products - Exclusion Products that do not fall into the scope of the regulation : 1. Products that utilize viable biological components for their intended purpose (e.g. lactobacillus); 2. medicinal products, cosmetics and food products, which are specifically regulated elsewhere. medicinal products covered by Directive 2001/83/EC. food products covered by Regulation (EC) 178/2002 cosmetics covered by Regulation (EC) 1223/ EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

16 MDR Scope - Borderline Cases 9) Products which combine a medicinal product or substance and a medical device, are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. It should be ensured that appropriate interaction exists between the two legislative acts in terms of consultations during the pre-market assessment and exchange of information on vigilance cases occurring with combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements of the device part should be adequately assessed in the context of the marketing authorization. Directive 2001/83/EC should therefore be amended. 16 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

17 MDR Borderline Cases It should be the responsibility of the Member States to decide on a case-bycase basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification across all Member States, particularly with regard to borderline cases, the Commission may, on its own initiative or at a duly substantiated request of a Member State, having consulted the MDCG, decide on a case-by-case basis whether or not a product or groups of products falls within the scope of this Regulation. 17 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

18 MDR Substance-based Medical Devices Rule 21 Devices that are composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body are: in class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose, in class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body, in class IIb in all other cases, except if they are applied on skin, in which case they are in class IIa, or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, in which case they are in class IIa. the up-classification to class III is only justified in cases where devices are systemically absorbed in order to achieve their intended purpose. 18 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

19 Self-Care Medical Devices Framework In accordance with Rule 21, no substance-based medical devices in future will fall under the risk class known as Class I. This means that in future, all Class I lozenges, nasal sprays, ear drops and moisturisers currently on the market or in development will require a conformity assessment procedure, together with a notified body, for the purpose of auditing productrelated aspects and the quality management system of the manufacturer. The concept of including certain products without a medical purpose in the scope of the MDR is new. Among others, these products include dermal fillers, such as injectable hyaluronic acid for treating wrinkles. 19 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

20 MDR Substance-based Medical Devices 42a) For class III devices a manufacturer may consult voluntarily an expert panel on its clinical development strategy and on proposals for clinical investigations. 44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body should be compulsory, Class IIb active devices intended to deliver medicines can also be subject to scrutiny as described in Annex IX or Annex XI of the MDR 20 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

21 MDR Substance-based Medical Devices HTA topics Art 2 (32) clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; (33) clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device; (37d) clinical benefit means the positive impact of a device on the health of an individual, to be specified as meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis or a positive impact on patient management or public health; (37b) clinical evidence means the clinical data and clinical evaluation results, pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer 21 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

22 MDR - Substance based Medical Devices Class III EUDAMED 39) For class III medical devices and implantable devices, manufacturers should summarize the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available. (39a) The summary of safety and clinical performance should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of the device when compared to the other diagnostic or therapeutic alternates and the specific conditions under which this device and its alternatives may be considered. (39b) The sponsor should submit a summary of results of the clinical investigation easily understandable to the intended user together with the clinical investigation report, where applicable, within the timelines. 22 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

23 MDR on Substance-based Medical Devices - Summary Substance-based medical devices are expressly recognised as such for the first time but assigned to higher risk categories Introduction of the new classification rule, Rule 21 Class IIb almost all Class IIa applied to the skin Class III if systematically absorbed only criterion for distinguishing between (substance-based) medical devices and medicinal products is still the products mode of action, whether or not the intended purpose is achieved by a pharmacological, immunological or metabolic mode of action. 23 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

24 MDR on Substance-based Medical Devices - Summary Strategy Which of my products are concerned? What about reclassification? 2022 last possible MDD certificate expires Needs, data, for conformity assessments? What additional clinical evidence is needed? For new product developments: Early Advice and Direction from a NB with experience of Substance-based Medical Devices 24 EUROPHARM SMC 2017 Dr. Simone Breitkopf, Alcon

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