Οι λύσεις μας
Βιομηχανικά εργαλεία και λύσεις συναρμολόγησης
Λύσεις
Service
Βιομηχανικά εργαλεία και λύσεις συναρμολόγησης
Expert Hub
Βιομηχανικά εργαλεία και λύσεις συναρμολόγησης
Products
Βιομηχανικά εργαλεία και λύσεις συναρμολόγησης
Power Equipment
Λύσεις
Αεροσυμπιεστες
Λύσεις
Προϊόντα
Αεροσυμπιεστες
Προϊόντα και λύσεις
Λύσεις
Αεροσυμπιεστές
Προϊόντα και λύσεις
Γεννήτρια αερίου
Προϊόντα και λύσεις
Membrane nitrogen generators
PSA Oxygen Generator
Αεροσυμπιεστές για ναυτιλιακές εφαρμογές
Υπερσυμπιεστές αέρα και αζώτου χωρίς λάδι
Εξοπλισμός επεξεργασίας αερίων και αέρα
Δράπανα
Προϊόντα και λύσεις
Στόλος ενοικιαζόμενων μηχανημάτων
Προϊόντα και λύσεις
Accessories
Στόλος ενοικιαζόμενων μηχανημάτων
Air
Nitrogen
Στόλος ενοικιαζόμενων μηχανημάτων
Offshore equipment
Oil-free air compressors
Στόλος ενοικιαζόμενων μηχανημάτων
Oil-lubricated air compressors
Στόλος ενοικιαζόμενων μηχανημάτων
Steam
Στόλος ενοικιαζόμενων μηχανημάτων
Εξυπηρετούμενες βιομηχανίες
Ελαφρύς εξοπλισμός κατασκευών και κατεδαφίσεων
Ηλεκτρογεννήτριες

What you need to know about the new medical devices regulation

The EU Medical Devices Regulation (MDR) requires all manufacturers in the EU to classify their medical and medical technology devices in risk classes and to have their risk and quality management systems audited. In this article you will find what companies now need to do about it.

Electronics_MDR_Medical Devices Regulation
What is the new medical devices regulation (MDR)?
The MDR covers practically all relevant aspects for the licensing and production of medical and medical technology devices.
The most important thing here is that all manufacturers need to establish a risk and quality management system and to have it audited. The MDR assigns all devices to risk classes. For example, pacemakers and artificial knee joints are assigned to class III, the most critical. Depending on the risk classes of their products, manufacturers must define specific production, quality assurance, and recall processes. It means that all products must be traceable, the tools, machines, and processes used for the production of these devices and the results achieved must all be documented.
Among other requirements, the regulation states that each individual device must be unambiguously identified, for example by a barcode.

The Medical Devices Regulation (MDR) supersedes Directives 93/42/EEC and 90/385/EC, and this new law adopted by the European Parliament must be followed by medical devices manufacturers. The audits will be carried out by the “notified bodies”, the inspection agencies that review and assess the technical documentation for medical technology and have the legal power to shut down a company if the relevant requirements are not attended. The period to submit the audit required by the regulation is three years, up to May 2020. If we assume that the notified bodies can carry out the audits in about one year, thus the manufacturers will have only about two years to implement the MDR. Be prepared! This is an extremely tight time schedule. Click here to learn how to meet the requirements and save money!