1. 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 1223/2009 jeffbrown144@gmail.com

2. Current Legislation Regulations relating to the safety and performance of medical devices in the EU were harmonised in the 1990s, following the New Approach legislative principles. The core legal framework consists of three directives: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) The aim of these Directives is to ensure a high level of protection for human health and safety and a good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.Directive 2007/47/EC

3. Revision of the Regulatory Framework  On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on ◦ i) medical devices and ◦ ii) in vitro diagnostic (IVD) medical devices.  These regulations, once adopted, will replace the existing three medical devices directives.

4. Anticipated approval and adoption by first half of 2016.  3-year implementation window (2019)

5.  Existing EU legislation, dating back to the 1990s, has not kept pace with the enormous technological and scientific progress in the past 20 years.  EU Member States interpret and implement the current rules in different ways ◦ Leads to different levels of patient and public health protection in the EU.

6.  Creates obstacles to the single market and thus reduces the benefits economic operators could reap from one of the main objectives of European integration.  Currently, it is not always possible to trace medical devices and in vitro diagnostic medical devices back to their supplier. New rules on traceability are therefore needed.

7.  Last but not least, patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices and in vitro diagnostic medical devices have been assessed, and what clinical evidence there is to show they are safe and effective. ◦ Greater transparency is needed.

8.  The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as ◦ the scope of the legislation, ◦ the pre-market assessment of devices, ◦ their control once on the market, ◦ the transparency of data concerning marketed devices and ◦ the management of the regulatory system by the authorities.

9.  Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified regarding genetic tests;  Stronger supervision of independent conformity assessment bodies (so called 'notified bodies') by national authorities;  More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;

10.  Clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors,  Extended database on medical devices (Eudamed)  Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);

11.  Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.

12.  Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.  Introduction of four different risk classes for IVDs, as it already exists for other medical devices.  Creation of a Medical Device Coordination Group to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.

13.  Medical devices and in vitro diagnostic medical devices produced in a third country and imported into the EU are subject to the same rules as medical devices produced within the EU.  Initiatives for harmonization are alive and well such as the former Global Harmonization Task Force, and the new International Medical Device Regulators Forum  The Commission proposals incorporate international guidelines into EU law to converge the regulatory requirements for medical devices and in vitro diagnostic medical devices in major economies.

14. Administrative Change (driven by transparency initiative): Standardized information to capture specific requirements references, such as Annex number & name, and New Regulation References. General Safety and Performance requirements will need a new Annex I checklist (prior ERC). Declaration of Conformity must be updated with standard information such as Annex number & name, Reg. references, UDI info, etc. NEW requirement for processes to address Lay-user IFU by stakeholder. The STED shall summarize the elements of the technical docs.

15.  Widespread impact to Clinical Evaluation Report  PSUR (periodic safety update report) required to summarize all post-market surveillance data, including sales & market share data.  SSCP (Summary of Safety and Clinic Performance) Class III and implants only.  CERs must consider alternative treatment options.  Clinical Investigation plan (product dependent)  PMCF Study must either be performed, or have a justification for not doing one.  CERs must justify the level of clinical evidence provided (safety and performance).  Expected Lifetime “card” for implants.

16. Expands due diligence for devices containing  CMR Cat. 2 Substances ◦ Requires “Special Attention”  CMR Cat 1a/1b substances ◦ approx. 1,480 substances (currently) ◦ Requires label warnings  EDC Substances ◦ Requires label warnings  Indications for Pregnant Women, Nursing Mothers, and Children ◦ Requires justification for use CMR = Carcinogenic, Mutagenic, Reproductive Toxins EDC = Endocrine Disrupting Compounds

17.  NEW – UDI required on CE Mark product. ◦ Already a U.S. requirement.  Update graphic components of the label. Impact to real estate on label may require extensive changes: ◦ Label redesign, fan fold, IFU, package change, etc.  Must potentially include labeling impact from ◦ New Clinical requirements (implant lifetime info), and ◦ New Restricted Substances (warnings, residual risks, or contraindications).

18. Gaps expected in documentation across 9 high level areas:  Risk management  Post Market Surveillance  Vigilance reporting  Clinical investigations  CAPA  Design controls  Classification of devices for EU  Preparation of the EU Declaration of Conformity  Interaction with EU Authorized representative

19. Contact Me: Jeff Brown  jeffbrown 144@gmail.com jeffbrown 144@gmail.com