The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be enforced starting May 25th, 2020. This new regulation repeals the Medical Device Directive (MDD) and Active Implantable Medical Device Directive.
What does this mean for medical device manufactures who sell their products in Europe?
Medical device companies that sell product in the European Union were given three years to transitions to meet the new MDR requirements, however an extension may be granted for special cases. Some of the more important highlights in the MDR are summarized below.
- The scope of the MDR has been broadened over the MDD to include cosmetic devices.
- Unique Device Identification (UDI) will be required for all device except custom-made devices and will aid in tracking devices, inhibit the use of unauthorized devices and help with the effectiveness of post-market safety related activities.
- General safety and performance requirements laid out in Annex I increase labeling requirements, for example IFUs (instructions for use) will need to be on the company’s website and also include links to the summary of safety and clinical performance information. The labeling requirements are extensive but clearly laid out.
- Annex I also set requirements for risk reduction, risk management, risk control and safety.
- Legacy devices will need to conform to the MDR. CE Markings given under MDD will not be grandfathered in under MDR.
- Increased emphasis on EUDAMED (the European Databank on Medical Devices). The purpose of EUDAMED is outlined in article 33 of the MDR and states that it can be used to inform the public about clinical investigations, enhance the tracability of devices as well as other applications.
- The rule classification system has been expanded by four additional rules.
- Rule 19 – Nanomaterials.
- Rule 20 – Invasive devices which are intended to administer medicinal products by inhalation.
- Rule 21 – Substances that are absorbed through the skin or introduced through an orifice.
- Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device.
- Every manufacturer will be required to have full access to all technical documentation of the device. Own Brand Manufacturers (OMB) that sell products entirely made by a second company and markets the product under its own name are expected to comply.
- A PMS (post-market surveillance) plan and a PMS Report or PSUR (periodic safety update report) is required, as stipulated in Annex III.
The MDR is a complex document and it would be difficult to summarize or highlight all the changes within the scope of this article. Medical device manufacturers selling products in Europe are encouraged to become familiar with the MDR (found here) or contact a regulatory specialist that is.