Medical Device Regulation (EU) 2017/745

The European Medical Devices Regulation 2017/745 (MDR) came into force on May 25, 2017 and will replace the two Directives 93/42/EEC (MDD) and 90/385 EEC (AIMDD) by May 26, 2020. It represents the regulatory framework for all medical devices, except in vitro diagnostic medical devices. It ensures quality and safety standards while safeguarding the free movement of goods. The Regulation reinforces the supervision of notified bodies, conformity assessment, clinical investigations and evaluation, vigilance, and market surveillance. Additional provisions detail the implementation of a unified device identifier (UDI) to ensure transparency and traceability of medical devices. 
I. Purpose, Scope, Definitions
Compared to the Medical Devices Directive (MDD), the Regulation significantly expands the scope of products covered and introduces some significant changes, namely reclassification of devices and a more more comprehensive control of high-risk devices. The Regulation introduces systematic clinical evaluation and post-market clinical follow-up for IIa and IIb.  More stringent requirements on expertise now apply to person responsible for regulatory compliance. Key elements of the existing approach, such as designation and oversight of Notified Bodies, conformity assessment procedures, clinical investigations, clinical evaluations, vigilance and market surveillance are significantly reinforced. EU level experts will be involved in the review of assessments performed by notified bodies.  
The European Commission will coordinate exchange of expertise. The European database of medical devices EUDAMED that will serve as a storage for essential information on economic operators, certificates, field safety corrective actions and regulatory actions is not yet functional.  The Regulation also covers devices without medical purpose such as contact lenses, dermal fillers, equipment for liposuction, high-intensity electromagnetic radiation and equipment for brain stimulation.  Products considered out of scope are combination products where the component other than device has principal function, in vitro devices, medicinal products, advanced therapy products, products derived from human blood, plasma and cells, cosmetic, animal and human transplants, cells and tissues, biological material or viable organisms and food.  
II. Placing Devices on the EU Market 
A device can be placed on the European market if it complies with this Regulation as set out in Annex I. Manufacturers have to demonstrate conformity with general safety and performance requirements. This also includes a clinical evaluation of the device. Key requirements are a system for risk management and a quality management system to keep products in conformity. 


Annex I - General Safety and Performance Requirements 

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.
  • Clinical Evaluation  "Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a Post-Market Clinical Follow-up (PMCF)"
  • Risk Management System   "Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I."  
  • Labeling and Instructions for use  "Manufacturers of devices shall ensure that the device is accompanied by a label that is indelible, easily legible and clearly comprehensible to the intended user or patient." 
III. Identification and Traceability
The new EUDAMED database will include information on devices, Unique Device Identifiers, economic operators (except for distributors), Notified Bodies, certificates,  
clinical investigations, vigilance, post-market surveillance and market surveillance (inspections, non-compliance, health protection measures). Database launch is expected in May 2022. 
The UDI system introduced by the Regulation ensures appropriate level of traceability of medical devices within supply chain. The system relies on internationally recognized nomenclature. The obligation to assign a Unique Device Identifier (UDI) applies as of 26 May 2021 for implantable and Class III devices. 

IV. Notified bodies 
The oversight of Notified Bodies increased significantly with the new Regulation. Notified bodies must employ sufficient technical, scientific and administrative personnel and 
comply with requirements set out in Annex VII. Applications for designation are assessed by Joint assessment team appointed by the European Commission. 

V. Classification of Devices 
Classification rules are governed by intended use. The devices are divided into Classes I, IIa, IIb, III based on invasiveness, duration of use, and risk for the patient. Disputes shall be referred to Competent Authority of the Member State. European Commission may implement acts to resolve divergent interpretation. 

IV. Conformity Assessment
 Conformity assessment is required prior to placing a device on a market or putting it into service . 
Class III – Annex IX 
Class IIb – Annex IX, chapters I and III 
Class IIb – type examination, Annex X 
Class IIa - Annex IX, chapters I and III 
Class IIa – Annexes II and III + Section 10 or 18 of Annex XI 

V. Classification of Devices 
Classification rules are governed by intended use. The devices are divided into Classes I, IIa, IIb, III based on invasiveness, duration of use, and risk for the patient. Disputes shall be referred to Competent Authority of the Member State. European Commission may implement acts to resolve divergent interpretation. 

VII. Post-Market Surveillance
The post-market surveillance plan shall cover collection of information to correctly characterize performance of the devices covered. The system shall allow a comparison between the device and similar products on the market and utilize suitable indicators and threshold values for reassessment of benefit:risk analysis. 

VI. Clinical Evaluation
The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements considering the characteristics of the device and its intended purpose.  
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