In 2017, two new European regulations were adopted to increase the availability of (new) medical devices for patients while ensuring the safety of medical devices. The Medical Devices Regulation (MDR) has come into effect in May 2020 and the In-Vitro Diagnostic Devices Regulation (IVDR) in May 2022. Examples of changes that will be initiated after the implementation of the MDR and IVDR are new classification systems of applications and a unique coding system with a catalog for applications.
In order to get a new application on the market, the main steps on the regulatory pathway are:
- Determine whether the product falls under the MDR or IVDR.
- Determine in which class described in the IVDR or the MDR the product belongs.
- Perform a conformity assessment by notified bodies and possibly EMA and/or the national competent authority (depending on the regulation and classification).
- If the product passes the conformity assessment, the product may bear a CE marking. The CE marking guarantees access to the European market.
Helpful links to help you through these steps
CE Tool: The CE tool explains the application of new legislation regarding medical devices, the MDR. It addresses questions such as: is the device or software a medical device? In which risk class does the medical device fall? By when does it have to comply with the MDR? And what is the step-by-step plan for certification?
Guide to new regulations on MDR/IVDR: A document developed by VWS, RIVM and IGJ to inform stakeholders who will be affected by the new regulations such as manufacturers, distributors and importers, but also patients and healthcare providers.
Report on the Impact of new European IVD classification rules on the involvement of notified bodies (RIVM): A study commissioned by the IGJ to understand the impact of the new IVDR. This report provides clear examples of the different classifications.
Medical Devices Regulation (MDR)
The MDR defines different categories in medical devices. A product is only considered a medical device if it belongs to one of the categories below. The category determines the terms and conditions of the clinical research and any other follow-up steps.
Medicines containing a medical device (combination products).
- Integral: the medical device and the medicinal product form an integral product. For example, syringes or inhaler that have been filled in advance.
- Packaged together: The medical device and the medicinal product are separate items in the same package. For example, a reusable insulin pen for insulin cartridges.
Medical devices where the active substance is additional to that of the device.
In other words: A medicine that is built into a medical device whose main mode of action is due to the device.
If there is any doubt as to whether and in which category the product belongs, this is called a borderline case. The national competent authority then determines on a case-by-case basis whether or not the product can be regarded as a medical device and in which category it belongs. In the Netherlands, the nationally competent authority is the Health and Youth Inspectorate (Inspectie Gezondheid en Jeugd, IGJ). The European Commission has also set up the Medical Device Coordination Group (MDCG) to ensure continuity in such decisions. The MDCG can be asked for advice in borderline cases.
In Vitro Diagnostic Devices Regulation (IVDR)
In vitro diagnostics are medical devices to test body material such as blood or urine. The IVDR introduces, among other things, different classifications of in vitro diagnostic tools. With the help of classification rules, the in vitro diagnostics are classified into one of the four risk classes (A-D). Class A includes the lowest risk class of devices and Class D includes the highest risk class of devices. The classification rules take into account factors such as the purpose of the test, the risk of reproduction, nature of the disease, etc., and the type of body material.
When an in vitro diagnostic device is placed in class B, C or D, notified bodies must carry out a conformity assessment of the product. This report by the RIVM provides clear examples of the different classifications.
Notified bodies & CE marking
Designated notified bodies carry out a conformity assessment of the product. A conformity assessment takes place before the product is allowed to enter the market. The product must meet all regulatory requirements. These condition are tested, inspected and certified. As soon as a product meets the regulatory requirements according to the conformity assessment, the manufacturer may place a CE marking on the product. If a product has a CE marking, it is allowed to enter the European market.
The EU member states, EEA member states and other countries with which the EU has concluded a mutual recognition agreement (MRA) designate notified bodies per directive or regulation. In the Netherlands, several notified bodies have been designated for the MDR and the IVDR. These notified bodies can be found in the NANDO (New Approach Notified and Designated Organisation) Information System, the database of the European Commission.