MDR/IVDR

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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:

These regulations replaced earlier directives and introduced stricter requirements for clinical and performance evidence, a new risk-based classification system, stricter Notified Body (NB) oversight, introduction of a unique coding system and an European database (EUDAMED).

Implementation is ongoing, with transition periods to allow certain products to remain on the market until 2027-2029, depending on their risk class. This is to ensure continued availability of safe devices while the system is being fully implemented.

In order to get a new product on the European market, the main steps on the regulatory pathway are:

  • Determine whether the product falls under the MDR or IVDR
  • Define the intended purpose and mode of action.
  • Determine the risk class described in the IVDR or the MDR.
  • Demonstrate safety and performance. This may include clinical investigations, performance studies and technical documentation.
  • Perform a conformity assessment, depending on the risk class a notified body must access the product.
  • Once all requirements are met, the product may bear a CE marking. The CE marking allows the product to be placed on the European market.

The European Commission provides information and guidance on the new regulations. 

Medical Devices Regulation (MDR)

A product is considered a medical device following the definition of the MDR:

A 'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 
    and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. 

The following products shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Some innovations combine a medical device with a medicinal product or medical substance. Depending on how the product works and what it is intended for, different rules may apply (MDR or the EU Clinical Trial Regulation (CTR)).

The MDR defines different classifications in medical devices. The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. There are four risk classes, class I (low risk), class IIa (moderate risk), class IIb (higher risk), class III (highest risk, e.g. implantable or life supporting devices). The class determines the terms and conditions of the clinical research, and thus clinical evidence, and any other follow-up steps.

In Vitro Diagnostic Devices Regulation (IVDR)

In vitro diagnostics are medical devices to test human body material, such as blood or urine, to provide information about health status, diseases, treatment response. The definition of an in vitro diagnostic medical device is as follows according the IVDR:

'In vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  • concerning a physiological or pathological process or state;
  • concerning congenital physical or mental impairments;
  • concerning the predisposition to a medical condition or a disease;
  • to determine the safety and compatibility with potential recipients;
  • to predict treatment response or reactions;
  • to define or monitoring therapeutic measures. 

    Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

The IVDR introduces, among other things, a risk-based classification 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 potential impact on patient care, the risk to public health, 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 be involved in the conformity assessment. This is a major change compared to previous legislation and has increased the regulatory requirements for many diagnostic tests.

Regulatory oversight and guidance

In the Netherlands, the Health and Youth Inspectorate (Inspectie Gezondheid en Jeugd, IGJ) is the competent authority for medical devices and invitro diagnostic devices. Their role includes ensuring that manufacturers comply with MDR/IVDR requirements, providing guidance when it is unclear how a product should be classified, and monitoring products already on the market for safety and performance.

In practice, IGJ may be consulted when there is uncertainty about classification or regulatory pathway, especially in early development stages or during clinical research planning. 

At the European level, the Medical Device Coordination Group (MDCG) provides guidance, expertise and supports harmonised interpretation of the MDR and IVDR across all EU countries. These guidance documents are widely used by regulators, notified bodies, manufacturers and also researchers. Although MDCG guidance is not legally binding, it is considered the reference standard for how the regulations are applied in practice.

Notified bodies & CE marking

Notified bodies are independent organisations designated by EU Member States to assess whether a product meets regulatory requirements. The 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 role of the notified body may include reviewing technical documentation, assessing clinical or performance data and auditing quality management systems. If the product meets all requirements, 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.

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