Ecker Medical Devices and IVDs

Fit for the new EU-Regulations: Your complete seminar for projekt, study and job
1. Auflage 2022
ISBN: 978-3-7562-7896-1
Verlag: BoD - Books on Demand
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 344 Seiten

With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges! 344 pages; 47 col. figures; 26 tables

Hon(FH)Prof. Dr. Wolfgang Ecker, MD, has played an active role in shaping the new EU regulations in the EU Council. He conveys the necessary know-how first-hand as former head of department in the Austrian Ministry of Health member in the important committees and working groups of the EU for medical devices and IVDs. He holds lectures at universities of applied sciences for medical technology and biomedical engineering and lectures for health and medical technology clusters as well as for players in business and healthcare.

Autoren/Hrsg.

Ecker, Wolfgang

Leseproben

Chapter 1. Overview of the New Regulatory System for Medical Devices and In Vitro Diagnostics in the EU Let us first take a look at the transition from the current system of EU directives to the new EU regulations for medical devices and IVDs (chapter 1.1.). Then we look at the construction principles of the new regulatory system (chapter 1.2.) and finally further to its central concepts for EU internal market access (chapter 1.3.). The most important documents of the new (and partly old) regulatory system are systematically discussed (section 1.4.). We then need a short regulatory compliance walkthrough along the product life cycle, from product development, preparation for market access, conformity assessment to the obligations when keeping the product on the EU market (section 1.5.). This fundamental orientation is concluded by the transition regime from the old directives to the new regulations with relevant time frames (section 1.6.) which have been adapted recently by the EU legislators to address urgent issues of the covid-19 crisis. 1.1. Transition from Directives to Regulations
In 2017, the EU legislator transformed the previous regulatory system for medical devices, consisting of 3 EU directives and their national implementations, into a new system of 2 EU regulations. as now directly applicable EU law (see Fig. 1): Regulation (EU) 2017/745 on medical devices (MDR)4, and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)5. Both regulations were developed in parallel and each consist of (see Fig.2+3) Recitals, i.e. intentions and objectives of the EU legislator which can be used as an aid to interpretation in the event of legal uncertainties, the Chapters and their Articles, with the core of both legal texts, and the Annexes, the binding, more technically oriented legal text, which supplement the chapters (for example Annex I on General Safety and Performance Requirements [GSPR; Annex II and III on technical documentation or Annexes IX to XI on conformity assessment modules [= modules of "European Premarket Approval"]). The MDR/IVDR entered into force at EU level on 25 May 2017; the date of application for the MDR has been – after an amendment of the MDR - 26 May 2021 (4-year transitional period); for the IVDR, the date of application will be 26 May 2022 (5-year transitional period). For the more special transition periods and regimes, see chapter 1.6. in this book. Fig. 1 From Directives to Regulations Fig. 2 MDR: Structure and Content Overview Fig. 3 IVDR: Structure and Content Overview 1.2. The New EU Regulatory System for Medical Devices and IVDs: The Building Principles
(See in particular Fig. 4) Both regulations are based on fundamental legal principles of the EU: the internal market concept and health protection (which primarily aims at safety and effectiveness, a high level of health protection, a positive clinical benefit/risk ratio according to the state of the art and minimization of risks and side effects). Both regulations follow basic regulatory principles of the internal market concept6, as is the 1.2.1. New legal framework for EU product legislation
This is about the new general legal framework for (many) EU product regulations (New Legislative Framework - NLF), which constitute the background philosophy of MDR and IVDR. NLF builds in a modernized form on important legal construction principles, which are essential for the understanding of both regulations: These are the Fig. 4 MDR-IVDR: Building Principles and Documents - Survey New Approach and the Global Approach. 1.2.2. The New Approach Under the New Legal Framework
The New Approach is essentially about the following: The two Regulations7 define in their respective Annexes I checklist-like the General Safety and Performance Requirements (GSPR; previously called Essential Requirements - ER) of the MDs or IVDs, which, insofar as they apply to a certain MD/IVD, must be fulfilled by the products on placing on the market or on putting into service. The details to these requirements incl. eventual verification procedures and tests, or on certain processes and procedures of the regulatory system, are provided outside the legal texts by harmonized European standards, the references (titles) of which are published in the Official Journal of the EU for the respective Regulation or Directive. These harmonized standards are not binding8, but contain in their Annexes Z (ZA, ZB, …) very specific presumptions of conformity with regard to the GSPR mentioned there for an MD/IVD; i.e. if the manufacturer follows the presumptions of conformity set out in Annexes Z (ZA, ZB,...) of the standards for the fulfilment of certain GSPR, the manufacturer is entitled to a presumption of conformity in this respect from its Notified Body (NB; "European Conformity Assessment Body") or from the market surveillance authority (this presumption may be falsified under certain conditions). The manufacturer may deviate from harmonized standards but must then sufficiently justify his alternative solutions for compliance with the relevant GSPR, which usually is associated with increased work load. In the absence of harmonized European standards, current international ISO or IEC standards will often be used alternatively9. Harmonized European standards can also provide presumptions of conformity in important processes and procedures (e.g. quality management systems, clinical investigations, usability, risk management, performance studies). The Harmonised Standards are drawn up by the European standardization bodies CEN and CENELEC (the latter for the electrotechnical sector) on the basis of standardization mandates of the EU Commission with the help of the standardization bodies of the Member States; they are jointly agreed and harmonized for certain regulations or directives after examination by the Commission. Their references (titles) are published 1-2 times a year in the Official Journal of the EU10. European standards are usually developed jointly with the global standards institutions ISO (<> CEN) and IEC (<> CENELEC); however, Appendices Z with the presumptions of conformity are only valid for the Harmonized European Standards. Further presumptions of conformity can now be provided for certain MD/IVD groups within the framework of both regulations, especially in the clinical area and for Annex XVI products of the MDR, by Common Specifications, (CS) in the form of legal acts of the COM. 1.2.3. The Global Approach under the New Legal Framework
The global approach deals with the conformity assessment (“European Premarket Approval”) of products on the basis of modular conformity assessment procedures. These must be selected according to the class of the MD/IVD, derived upon the classification rules of Annex VIII of the MDR/IVDR. For medium and higher classes of the MD/IVD, conformity assessment is carried out by so-called Notified Bodies (NB). Notified Bodies are appointed by the Member States after their proven qualification and competence in a complex, now European supervised procedure for specified product areas, specified areas of horizontal technical competence (e.g. certain technologies (e.g. nanotechnology) or processes (e.g. molecular biological diagnostics), so-called "horizontal competence codes" certain conformity assessment modules (Annexes IX-XI or parts thereof)11. The positive completion of approval modules (or certain parts12 thereof) by the manufacturer is documented by certificates (NB-certificates) from the NB (valid for a maximum of 5 years; content of NB-certificates see Annexes XII in both Regulations). The aim of conformity assessment is the CE marking of conformity as a sign of successful EU approval (the correct CE marking is set out in Annex V of both Regulations). The CE marking not only includes proof of compliance with the requirements of MDR/IVDR but also of all EU legal acts that also apply to the product and require CE marking13 ("inclusive" CE marking). The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging. The CE marking is supplemented by the 4-digit identification number of the NB (if) involved in the conformity assessment14. In addition, the manufacturer confirms the conformity of his medical devices/IVDs with the MDR/IVDR and the other EU legal acts applicable to his product, which also require an EU declaration of conformity in addition to the MD/IVDR, by an EU Declaration of Conformity ("inclusive" EU...