Medical devices in Europe have been regulated by the Medical Device Directive (MDD), directive 93/42/EEC. As it can be seen from the directive’s number it dates back to 1993. It has over the years been modified, latest in 2007. So, until now medical devices have been regulated by decade old directives.
It might have been through this fact that several scandals have been recovered within the medical device industry over the years. In the late ‘90 there was the Boneloc scandal but later on several journalists from all over the world have recovered scandals with a large variety of implantable medical devices. The devices that were meant to help patients simply made these same patients’ lives more miserable than before.
Maybe for these reasons the European union has announced a replacement for the MDD. As of May 26, 2020 the directive should have been replaced by the Medical Device Regulation (MDR), Regulation (EU) 2017/745.
The new MDR is in many ways different from the old MDD. Basic principles are changed and will require new procedures for manufacturers, authorized representatives and importers of medical devices. There is still a classification of medical devices into 4 classes; class I, class IIa, class IIb and class III, still meaning the lowest class is class I.
One of the new issues in the MDR is introducing the Eudamed database. This database is meant to register all information related to medical devices; registration of devices, identification, registration of economic operators, notified bodies, clinical investigations, market surveillance, and vigilance and post-market surveillance. It is a very ambitious database, and we don’t need to tell that it’s far from being ready.
Two interesting new requirements for manufacturers of medical devices are the introduction of Unique Device Identification (UDI) and Quality Management System (QMS). This means that manufacturers will need to have a system into place that identifies their devices uniquely and need to have a QMS in place.
Luckily the MDR only dictates some overall requirements to the QMS. This has led to the assumption among many parties in the industry that manufacturers now are obliged to be ISO 13485 (specific QMS for medical device) certified in order to live up to the requirements. This couldn’t be more wrong. The MDR doesn’t say anything about any specific QMS based on ISO 13485, as long as you follow the requirements you can make your own QMS in an Excel spreadsheet or follow any other standard like for instance ISO 9001. That said you can in some cases have an advantage if you are certified according to ISO 13485, but that’s another story.