What are the EU MDR changes compared to MDD?
The European Union Medical Device Regulation (EU MDR) replaces the previous European Union Medical Device Directives (EU MDD). In particular, the new EU MDR (2017/745) amends previous directive 2001/83/EC and repeals council directives 90/385/EEC and 93/42/EEC.
The following are the six major differences between the old EU MDD and the new EU MDR:
What is MDR and IVDR?
The EU MDR regulations do not incorporate In Vitro Diagnostic Regulation (IVDR); this IVDR equipment is governed by a separate EU regulation 2017/746. However, Article 1 (point 7) of the MDR regulation clarifies the relationship between the IVDR regulation and the EU MDR regulation: if a device has both IVDR components and other medical device components, then the IVDR parts of any device are governed by the 2017/746 regulation, but the remainder of the device is covered by the MDR EU regulation.
In vitro medical devices are devices intended to be used for diagnostic, monitoring, or compatibility measurement of specimens outside of the human body. The new EU MDR regulations includes requirements for these types of products.
MDR technical maps
As has been the case with the EU MDD, all medical device products that have a CE mark need to have a technical file created, which proves that the device meets all the requirements of the EU directives for CE-marked products. Annex II of the new EU MDR includes revised requirements for what needs to be included in the contents, as well as the structure, or the technical file.
As per Annex II of EU MDR, the technical documentation needs to be clear, organized, readily searchable, and unambiguous. The elements to be include in the technical file are:
This practice matches with ISO 13485:2016 clause 4.2.3, which requires the device manufacturers to create a technical file, or a medical device file.
What are Class I medical devices?
Class I medical devices are medical devices that are considered to be non-invasive, and include the following categories: sterile, measuring, or reusable surgical equipment. Some Class I devices can be self-certified, where Notified Body involvement is not required; however, you must still implement a QMS.
What are examples of medical devices?
The EU MDR regulations includes five classes of medical devices in Annex VIII. This annex classifies products according to 22 rules. Below is a short summary, with some examples of each:
Class I (Low Risk): Non-sterile devices, or devices without a measurement function. These devices can be self-certified. For example: reusable surgical equipment (e.g., scalpel), stethoscopes, wheelchairs.
Class I Special Function (Low/Medium Risk): Sterile devices, or devices with a measurement function. Non-invasive devices that do not meet the requirements of other classes, and invasive devices that are intended for transient use. For example: reprocessed devices, measurement devices, devices delivered sterile.
Class IIa (Medium Risk): Invasive devices intended for short-term use. For example: tooth implants, tracheotomy tubes, syringe, X-ray device.
Class IIb (Medium/High Risk): Invasive devices intended for long-term use. For example: implantable birth control, blood bags.
Class III (High Risk): Implantable medical devices intended for long-term use. For example: pacemakers, breast implants, spinal disc implants, drug-coated stents.
What is MDR in healthcare?
The EU MDR regulations are intended to improve the safety and performance of medical devices in Europe and, as such, intends to provide a high level of protection for the health of patients and users of these medical devices. To do this, the EU MDR regulations sets a high standard for the quality and safety of medical devices to better address the safety concerns of medical devices.
So, what is the EU MDR’s relationship to healthcare? The EU Medical Device Regulation is setting a framework to ensure that medical devices manufactured or imported into the European Union meet this high level of safety and quality. By improving the safety and performance of medical devices, the EU MDR regulation intends to improve the safety of healthcare.