The medical device regulation mdr, just like the medical device directive mdd, splits medical devices into classes 1, 2a, 2b and 3. Medical devices are classified into class i, ii, and iii. The classification rules assign devices with higher risks to the higher classes. Mdr and class i medical devices whats in, whats out. More specifically, any medical device manufactured, repackaged, relabeled, andor imported by any company or firm to sell in the u. Patients should use them for a shortterm period, any less than 30 days. All medical devices sold in the united states are regulated by the u. Medical device regulation eu mdr implementation guide. The classes are often written using roman numerals class i, iia, iib and iii. Medical devices of class iia could be such as surgical gloves, hearing aids, diagnostic ultrasound machines, etc.
For class iii devices, a premarket approval application pma will be required unless your device is a preamendments device on the market prior to the passage of the medical device amendments in. Mdr implementation guide for class 1 medical devices. Our guide is simple to understand and will allow you to save time and money when implementing the new regulation. The device classification regulation defines the regulatory requirements for a. Youll find all those rules on the medical device regulation mdr 2017745 annex viii. Three different subclasses of class i medical devices will get an additional four years to come into compliance with the new regulation.
Regulatory control increases from class i to class iii. This guidance applies to manufacturers of class i medical devices, including accessories but excluding devices intended for clinical investigation and custom. Classification medical device in eu medical device. Regarding class 1, i have been advised that the pi is not required on a class 1 product, that a upc will meet udi requirements. Classification of medical devices and their routes to ce. Situations in which a class 1 device will not be considered compliant with the uk medical devices regulations 2002 include the following.