New Regulation (Draft) for Medical Devices September 11, 2013 Dr. med. Christian Schübel
History Directive 93/42/EEC Medical Devices Directive 90/385/EEC Active Implants Regulation for Medical Devices Directive 2007/47/EC Proposal of the European Commission Draft Report ENVI European Parliament Directive 93/42/EEC amended Directive 90/385/EEC amended Revision (Recast 2008) 4
Regulatory Framework within the EU Draft by the European commission (supported by the Member States) Decision by the Committees of the European Parliament First Reading of the European Parliament Discussion within the European Council Sept. 2012 April 2013/ postponed to Sept. 2013 Nov. 2013 2. Reading of the European Parliament Final Decision by the European Council 2014 4
New Reguation and SME Increased Requirements by: Complexity of the European framework Increased requirements on the devices itself and up-classification Clinical evaluation and need on clinical trials Vigilance system
Regulatory Framework Regulation Approx. 60 implementing acts within the regulation However, there is a need for national (member states) medical device acts 4
Scope The Scope of the directive will be extended: Devices for sterilisation and disinfection will be medical devices Products just with an aesthic claim will be medical devices 4
Scrutiny Procedure for High Risk Devices Paragraph 44 Scrutiny procedure for all class III Medical devices performed by the Medical Device Coordination Group Alternative: Approval process for high risk devices 3 Month?
Classification Devices shall be divided into classes I, IIa, IIb and III Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business. At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision.
Classification Commission shall be empowered to adopt delegated acts regards the following: a) deciding that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class; b) amending or supplementing the classification criteria set out in Annex VII. 4
Classification Rule 19 All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient s or user's body when the device is used within its intended purpose. DEF: 50 percent of the particles between 1nm and 100nm related to the smallest diameter. 4
Classification Rule 20 All devices intended to be used for aphaeresis, such as aphaeresis machines, sets, connectors and solutions, are in class III.
Classification Rule 21 Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class III. Deleted within the proposal of the European Parliament 4
Summary Report on Safety and Performance Article 26 Necessary for all class III medical devices and implants Addressed to the intended user This report is public Increase of transparency
Clinical Investigation In the case of implantable devices and devices falling within the class, clinical investigation shall be performed Demonstration of equivalence shall generally not be considered as sufficient justification to follow the literature route The approval of the Ethic Committee is soley based on national legislation The technical performance of the device, the clinical safety and efficacy of the device has to be investigated (Report European Parliament)
Post Market Clinical Follow-Up The requirements as outlined in MEDDEV 2.12/2 Clinical follow up will be implemented into the European regulation.
Vigilance Changes of Definitions incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable side-effect serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: death of a patient, user or other person, temporary or permanent serious deterioration of the patient's, user's or other person's state of health, serious public health threat;
Vigilance Trend Reporting Manufacturers of devices classified in class IIb and III shall report to the electronic system: any statistically significant increase in the frequency or severity of incidents that are not serious incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis
Report EU-Parlament - Approval Process Centralised Procedure: Innovative active implantable devices Innovative Drug-Device-Combinations Products Innovative products containing non-viable derivatives of human or animal origin
Report EU-Parlament - Approval Process Decentralised Procedure (Article 41a): Class III medical devices Non-innovative implants Non-innovative combination products Non-innovative products containing non-viable derivatives of human or animal origin
Regulatory Framework within the EU Draft by the European commission (supported by the Member States) Sept. 2012 Decision by the Committees of the European Parliament First Reading of the European Parliament Discussion within the European Council April 2013/ Sept. 2013 Nov. 2013 2. Reading of the European Parliament Final Decision by the European Council 2014
New Regulation - Conclusion Increasing requirements for high risk devices and implants Discrimination between class III devices/implants and all other devices New approach is still remaining High complexity of the vigilance system Multiple smaller to medium changes