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EU MDR or IVDR: Key considerations for your Medical Device
Before 2017, there were 3 directives in Europe linked to differend kinds of medical devices: one being the Active Implantible Medical Device Directive (AIMDD), another one was the Medical Device Directive (MDD) and a third one was the In-Vitro Diagnostics Directive (IVDD). In 2017, these were changed to two European Regulations instead of directives being the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). In this articles we explore what are these two regulations and how do they compare to one another.
What are MDR and IVDR?
MDR
EU 2017/745 Medical Device Regulation is the European regulation regarding medical devices that was published in 2017. It replaces the former Active Implantable Medical Device Directive and the Medical Device Directive. It covers the European requirements related to medical devices in general.
Since the MDR came into force in 2017, the timelines for application have shifted a few times. Currently, they look like this:
IVDR
EU 2017/746 In Vitro Diagnostic Regulation is the European regulation regarding In Vitro diagnostics. It was also published in 2017 and replaces the former In Vitro Diagnostics Directive. It covers the European requirements for in vitro diagnostic devices specifically. Same as for the MDR, the timelines for application have been updated since its publication. The last proposal published in January 2024, in order to prevent shortages can be found here. Currently, the timelines, taking into account the latest proposal, look like this:
What is the difference between MDR and IVDR?
Applicability
Both are regulations, but where MDR focuses on medical devices in general, IVDR is solely for in-vitro diagnostics.
If we look at the definition of a medical device according to Article 2 of the MDR, it is:
"'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."
Examples of Medical Devices are hypodermic needles, hip replacement transplants, infusion pumps and many other. Interestingly, the 4th bullet point in the definition does mention in-vitro examination. However, Article 1(6) MDR specifically states that the Regulation does not apply to in vitro diagnostic medical devices covered by Regulation (EU) 2017/746. Therefore, an IVD can be seen as a subset of the medical device family, but with its own governing Regulation IVDR (EU) 2017/746.
The definition of an IVD according to Article 2 of the IVDR is as follows:
"'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 reaction
to define or monitor therapeutic measures
Specimen receptacles are also deemed to be in vitro diagnostic medical devices."
Examples of IVDs are COVID tests, genetic tests, cholesterol tests, etc.
In the IVDR there is an exclusion for invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen. An example of that is a spinal needle for CSF collection. Even though the sample that is obtained by use of this spinal needle will be analyzed in vitro, the needle itself is considered to be a medical device.
Classification
Even though the structure of both regulation is similar, it's not exactly the same. The MDR consists of 123 articles while the IVDR is slightly shorter with 113 articles. As discussed above, both are distinct regulations focussing on different products. Both apply a risk-based approach in their classification of products within their own scope. However, that classification is specific to each of the two regulations.
| MDR | IVDR |
|---|---|
| I, Is, Im, Ir - low risk | A - low patient and public health risk |
| IIa, IIb - medium risk | B - moderate patient risk and/or low public health risk |
| III - high risk | C - high patient risk and/or moderate public health risk |
| D - high patient risk and high public health risk |
Unique device identification
Article 27 of the MDR and Article 24 of the IVDR lay down that the UDI system needs to consist:
of production of a UDI that comprises a UDI device identifier ('UDI-DI') specific to a manufacturer and a device, providing access to the information and a UDI production identifier ('UDI-PI') that identifies the unit of device production and if applicable the packaged devices
placing of the UDI on the label of the device or on its packaging
storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this article respectively
establishment of an electronic system for unique device identification ('UDI database')
So for both types of products, the UDI requirements are similar. The EU provides assistance in this matter in its helpdesk.
Pre- and Post Market Data
One of the requirements of the MDR is to provide data from clinical investigations and evaluations and continuously update it also when the device is already on the market. The MDCG guidances provide additional detailed information to clarify the requirements:
| Reference | Title |
|---|---|
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices |
| MDCG 2023-7 | Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence |
| 2023/C 163/06 | Commission Guidance on the content and structure of the summary of the clinical investigation report |
| MDCG 2021-28 | Substantial modification of clinical investigation under Medical Device Regulation |
| MDCG 2021-20 | Instructions for generating CIV-ID for MDR Clinical Investigations |
| MDCG 2021-8 | Clinical investigation application/notification documents |
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
| MDCG 2020-13 | Clinical evaluation assessment report template |
| MDCG 2020-10 | Guidance on safety reporting in clinical investigations |
| MDCG 2020-8 | Guidance on PMCF evaluation report template |
| MDCG 2020-7 | Guidance on PMCF plan template |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence |
| MDCG 2019-9 | Summary of safety and clinical performance |
Also for the IVDR, there specific guidances available:
| Reference | Title |
|---|---|
| MDCG 2022-20 | Substantial modification of performance study under Regulation (EU) 2017/746 |
| MDCG 2022-19 | Performance study application/notification documents under Regulation (EU) 2017/746 |
| MDCG 2022-15 | Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD |
| MDCG 2022-9 | Summary of safety and performance template |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) |
Notified Bodies
The NANDO (New Approach Notified and Designated Organisations) website provides a list of all Notified Bodies for Europe. Notified bodies are the independent organizations that review the technical documentation and provide CE marking for all medical devices except for class I and all IVDs except for class A. Currently (March 2024), there are 44 accredited Notified Bodies for the MDR and 12 for the IVDR. This is still far less than there were for the MDD and IVDD. It's important to understand that your Notified Body of choice is accredited for the specific legislation under which your product falls, but as well that the device itself is within scope of its accreditation. This information can also be found for each Notified Body on the NANDO website.
The MDR and the IVDR have a similar structure but do have their own application, requirements and NBs. It's important for manufacturers to start by making sure they know to which of these regulations their device belongs and which classification applies. Based on this, the further requirements will follow.
If you'd like to know how Matrix Requirements can help you creating compliant documentation for your regulatory submissions, don't hesitate to book a demo.