On May 26, 2020, the new European Medical Device Regulation (MDR 2017/745) that repeals the old Medical Devices Directive (93/42 / EEC) and (90/385 / EEC) will enter into force.
Sanitary products are characterized by constant evolution and closely linked to technological development and innovation. To get closer to an idea of the volume, we talk about a market with more than 500,000 Sanitary Products and Sanitary Products in vitro and a number of patents of around 12,500 worldwide.
Medical devices are created to diagnose, treat, cure and / or alleviate a disease, injury or deficiency. For this reason, it is essential that all of them are subject to international legislation and certification. Global compliance
The current legislation on medical devices dates back to the 1990s. Despite the changes it has undergone over the years, it was necessary to carry out a thorough general review of the regulatory framework to adapt it to technological progress and innovations of the sector that would allow consolidating reinforced health and safety guarantees.
What has been revised in the new European regulation on medical devices?
Regulation (EU) 2017/745 of the European Parliament and of the Council, of 5 April 2017, on medical devices (hereinafter, the “MDR”) that repeals Directive 90/385 / EEC (AIMDD) and Directive 93 / 42 / EEC (MDD), entered into force on May 25, 2017 and applies as of May 26, 2020.
The MDR regulates, among others, the following aspects:
- Medical devices for human use and related accessories.
- Devices not commercialized but used in the context of a commercial activity to provide a diagnostic or therapeutic service through the services of the information society or by other means of communication.
- Products that do not have a medical destination and are listed in Annex XVI.
What are the main changes of the MDR on medical devices?
The MDR introduces new classification rules and modifies some of the MDD Directive, the classification of medical devices being more rigorous (ref. Annex VIII of the MDR).
It maintains 4 risk classes: I, IIa, IIb and III. Now, active implantable medical devices enter class III.
It presents the economic operators. Manufacturer, Agent, Importer and Distributor. In addition, it defines specific obligations.
It introduces the need for the manufacturer to have financial coverage and a person responsible for compliance with the law.
Strengthens the need for the Manufacturer to have a Risk Management System, a Post-Marketing Surveillance System and an Incident Reporting System.
It reinforces the need for the manufacturer to demonstrate compliance with clinical data.
It presents the preparation of specific documents by the manufacturer.
- Summary of safety and clinical performance for devices classified in class III and for implantable devices.
- Post-marketing surveillance report for devices classified in class I and periodic safety update report for devices classified in classes IIa, IIb and III.
- Trend reports.
- Card for patients with implantable devices.
Strengthens the concept of traceability of the device with the creation of the Unique Device Identification system.
Strengthens the use of EUDAMED for the collection of device information in a single European database.
Eliminates conformity assessment procedures based on product quality assurance (Annex VI of the MDD) and statistical verification of the product (Annex IV of the MDD with sampling).
