KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE

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1 RNI Conseil 2017 Tous droits réservés Toute reproduction interdite sans l'autorisation de l'auteur. KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE Anne Laure TARDY, PhD 26 October 2017 Produits de Nutrition & de Santé Stratégie Règlementaire Expertise scientifique, médicale et toxicologique Expertise à l international

2 Table of content Products regulatory frameworks & definition Classification of the products Key actors of the systems Safety/ efficacy requirements & drafting application Marketing procedure and authorization Conclusion

3 PRODUCTS REGULATORY FRAMEWORKS & DEFINITION

4 Regulatory framework of medical devices KEY DATES IN THE APPLICATION OF THE NEW MDR Enter into force : 26 may 2017 Shall apply from 26 May 2020, with the exception of the o Chapter IV on notified body: 26 november 2017 o Chapter VIII on the cooperation with the MS : 26 may 2018 KEY OBJECTIVES OF THE NEW MDR Improve security for patients and users Improve the traceability of MD Strengthen the role of notified bodies Specify the obligations of manufacturers, importers and distributors Strengthen the requirements for clinical evidence

5 Definition of medical device According to the Article 2 of the Regulation (EU) 2017/745: Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for [ ] specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, [ ], investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, [ ], and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

6 Definition of medical device According to Annex 1 of the Regulation (EU) 2017/745 : GENERAL REQUIREMENTS, devices should Achieve the performance intended by their manufacturer Be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. Be safe and effective and shall not compromise the clinical condition or the safety of patients or of users Constitute acceptable risks when weighed against the benefits to the patient REQUIREMENTS REGARDING DESIGN AND MANUFACTURE REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

7 Regulatory framework of medicinal products KEY CONTENTS Requirements and procedures for the marketing authorization Rules for the constant supervision of products after their authorization Harmonized provisions in areas such as the manufacturing or advertising SPECIFIC RULES FOR CERTAIN TYPES OF MEDICINAL PRODUCTS Regulation (EC) No 141/2000 : orphan medicinal products Regulation (EC) No 1901/2006: medicinal products for children Regulation (EC) No 1394/2007 : advanced therapy medicinal products Directive 2004/24/EC : on specific provisions applicable to herbal medicinal products

8 Definition of medicinal products According to Article 1(2) of the Directive 2001/83/EC: Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings presentation of the medicinal product and to the claims made for it (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. its function and intended use. According to settled case law of the European Court of Justice (ECJ), 'a product is a medicinal product if it falls within either of those two definitions'.

9 CLASSIFICATION OF THE PRODUCTS

10 Classification rules of medical devices According to Article 51 & Annex VIII of the Regulation (EU) 2017/745: Devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose and their inherent risks. Any concern between the manufacturer and the notified body shall be referred for a decision to the competent authority Important definition: Duration of use Transient : continuous use for less than 60 minutes. Short term : continuous use for between 60 minutes and 30 days. Long term : continuous use for more than 30 days Invasive and active devices

11 Classification rules of medical devices According to the Annex VIII of the Regulation (EU) 2017/745: 22 rules to determine the class of the MD (vs 18 rules in the current regulation) Rules 1 to 4 : Non-invasive Devices (ex: rule 4: non-invasive devices which come into contact with injured skin or mucous membrane) Rules 5 to 8 : Invasive Devices Rules 9 to 13: Active Devices Rules 14 to 22 : Special rules Rule 14 : All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product are classified as class III Rule 19 : Device containing nanomaterials Rule 21: Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body

12 Classification of medicinal products According to Articles 70 to 75 of the Directive 2001/83/EC: Art 70: CA specify the classification of the medicinal product into: a medicinal product subject to medical prescription, a medicinal product not subject to medical prescription. Art 72: Subject to medical prescription if they: are likely to present a danger even when used correctly, if utilized without medical supervision are frequently used incorrectly and are likely to present a danger to human health contain substances thereof, the activity and/or adverse reactions of which require further investigation are normally prescribed by a doctor to be administered parenterally Art 73: Draw up a list of the medicinal products subject to medical prescription on their territory.

13 Products classification: where is the limit? What are borderline products? An increasing number of products may fall within the scope of two definitions: medicinal products and food products/food supplements, medical devices, biocides or cosmetics Tools to help the stakeholders: Manual of Decision (Manual on borderline and classification in the community regulatory framework for medical devices (Version 1.17 ( )) MEDDEV (Meddev 2.4/1 Rev 9 June Classification of medical devices) Guidelines about «A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE) (EMA, 2006) If uncertainty over the classification, the stricter regime of medicinal products applies: ultimate aim being to protect the user.

14 KEY ACTORS OF THE SYSTEMS

15 Key actors of the medical devices NATIONAL COMPETENT AUTHORITY Responsible for market surveillance and / or vigilance (ex: materiovigilance, product classification, control of advertisement ) MANUFACTURER a natural or legal person who manufactures or fully refurbishes a device, and markets that device under its name or trademark Ensure that product is compliant with requirements of the MDR (article 10) NOTIFIED BODY Conformity assessment body designated in accordance with the MDR Submission of applications: before December 1, 2017 New requirements set out in Appendix VII Inspection (3 experts + Country Competent Authority) for documentation reviews and on-site audit of each candidate Designation : no later than 1 October 2018 (quite late for implementation of the Regulation as of May 2020) IMPORTER AND DISTRIBUTOR

16 Key actors of the medical devices EUDAMED- European database on medical devices (Article 33 of the Regulation (EU) 2017/745): Objectives Transparency and adequate access to information Provide a sound basis for regulatory decision-making Build confidence in the regulatory system Several level of access depending on the user : member states, notified body, manufacturer & public Eudamed shall include the following electronic systems: the electronic system for registration of devices the UDI-database (Unique Device Identifier) the electronic system on registration of economic operators the electronic system on notified bodies and on certificates the electronic system on clinical investigations the electronic system on vigilance and post-market surveillance the electronic system on market surveillance

17 Key actors of the medicinal products European Medicine Agency Draw up scientific opinions for the evaluation of medicines for the EU institutions and the Member States. Seven scientific committees : Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Committee for Advanced Therapies (CAT) Paediatric Committee (PDCO) Pharmacovigilance Risk Assessment Committee (PRAC) National Medicine Agency For national authorization procedure: mutual recognition procedure and decentralized procedure Equivalent missions of EMA but at national level

18 SAFETY/ EFFICACY REQUIREMENTS & DRAFTING APPLICATION

19 Annex II Safety/ efficacy requirements & technical file for medical devices The technical file is mandatory for all the products (Annex II & III) Device description and specification Label / packaging/ notice Design and manufacturing information General safety and performance requirements Benefit-risk analysis and risk management Product verification and validation (clinical, preclinical, additional information required in specific cases Technical documentation on post-market surveillance (Annex III) Standards are not mandatory but they have a particular importance meeting them when they exist makes it easier to meet the corresponding general requirements. Some, known as "harmonized", even presume compliance with these requirements. It is necessary to identify the applicable standards and to motivate their possible non-application

20 Safety/ efficacy requirements & technical file for medical devices Standard for risk management NF EN ISO 14971: 2013 Application of risk management to medical devices Global evaluation to manage all the risk link to the product (at each step of the life of the product): identification, evaluation, control, residual risk assessment Standards for safety evaluation ISO : Biological evaluation of medical devices Standards for performance evaluation NF EN ISO 14155: 2012 on clinical investigation MEDDEV Guidances 271 rev 4 for drafting clinical evaluation report Standards for quality management NF EN ISO 13485: 2016 : on quality management

21 Safety/ efficacy requirements & technical file for medical devices Biological evaluation report ISO : Biological evaluation of medical devices

22 Safety/ efficacy requirements & technical file for medical devices Clinical efficacy & safety: clinical evaluation report KEY CONTENTS Must be draft for all MD class (advise : follow the MEDDEV 271 rev 4) Objective: Compile, evaluate and analyse the clinical data to justify the performance and safety through the entire life of the product Appendix A9 : Example of template Equivalence demonstrated based on MEDDEV guidelines Data in the literature available to answer General requirements (safety, performance, benefit / risk ratio, secondary effects) based on the MEDDEV criteria DRAFT OF CLINICAL EVALUATION REPORT Equivalence not demonstrated Data from the literature are insufficient Clinical investigation is required DRAFT OF CLINICAL EVALUATION REPORT

23 Safety/ efficacy requirements & technical file for medical devices Clinical efficacy & safety: clinical evaluation report Conformity assessment with requirement on: safety acceptable benefit/risk profile performance acceptability of undesirable side-effects Data issued by the manufacturer (pre & post marketing, pre clinical studies.) Data issued from the literature on the MD or on an equivalent MD (must be clear and justified) sample size and power calculation relevance of endpoints inclusion and exclusion criteria methods used for quantifying symptoms and outcomes reporting of serious adverse events Guidance 271 rev 4 du MEDDEV

24 Safety/ efficacy requirements & CTD dossier for medicinal products Common technical document Since July 2003, mandatory format for new drug applications in the EU The dossier is organized into five modules : Module 1 is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.

25 Safety/ efficacy requirements & CTD dossier for medicinal products Non clinical overview and non clinical summaries

26 Cinical overview and clinical summaries Safety/ efficacy requirements & CTD dossier for medicinal products

27 MARKETING PROCEDURE AND AUTHORIZATION

28 Marketing procedure and authorization for medical devices CE marking of conformity or CE marking Definition = a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the Regulation For class I medical devices Autocertification by the manufacturer For the other classes Evaluation by the notified bodies Obtention of CE marking gives the autorisation to commercialize in all the EU Member States

29 Marketing procedure and authorization for medicinal products Required before launching a drug on the European market EU authorization are granted by the EC through the centralized procedure following an application to the EMA. National authorizations are granted by the Member States through the national competent authorities Centralized procedure (Regulation (EC) N 726/2004) A single scientific assessment procedure of the highest standard for the medicinal products falling within its scope Mandatory for certain drugs & optional for other Results in a single marketing authorization that is valid in all Member States and offers, among other things, the benefit of direct access to the EU market.

30 Marketing procedure and authorization for medicinal products Decentralized procedure (Directive 2001/83/EC) For products that have never been marketed in a MS The 'reference Member State carries out the initial evaluation and issues a draft assessment report. The other MS in which applications were submitted either agree with the evaluation or ask further questions. Once all issues are resolved and the application is successful, national marketing authorizations will be issued in the reference MS and the other MS concerned Mutual recognition procedure (Directive 2001/83/EC) Applies to medicinal products that have already been authorized in a MS. The MS that issued the original national marketing authorization submits its evaluation to the MS in which the stakeholder wants to market its product These are then asked to mutually recognize the marketing authorization. If the applicant is successful, each MS concerned will issue a national marketing authorization.

31 CONCLUSION: KEY MESSAGES TO BRING HOME

32 Conclusion: key messages to bring home MEDICAL DEVICES MEDICINAL PRODUCTS/ OTC Indication Medical purposes Medical purposes Mode of action «Mechanic» Pharmacological Actors Dossier Marketing autorisation Procedure Manufacturer/ Notified Body/ National competent agency Technical File+ standards & guidances (advised +++) Auto- certification & notified body CE marking -> all MS Manufacturer/ National& European Competent Agency CTD Dossier (mandatory) National& European Competent Agency Centralized -> all MS Decentralized & mutual recognition procedure -> specific MS A lot of other things : quality assessment, post marketing surveillance have to be taken into account

33 Mail:

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