The European Medical Devices Regulation (EU) 2017/745 sets out strict safety and quality requirements for medical devices, the fulfillment of which requires third-party lab testing.1 Manufacturers and importers must meet these standards to market their products within EU member states.
Measurlabs offers a comprehensive range of medical device testing services, from biocompatibility to microbiological cleanliness, sterility, and medical device packaging testing. Do not hesitate to contact us to discuss the options for evaluating your device’s compliance with the EU MDR.
Table of contents
Which devices does the EU MDR cover?
In Article 2(1) of the MDR, a medical device is defined as “any instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for a medical purpose, such as diagnosis, prevention, or treatment of disease or investigation or modification of the anatomy. In addition, devices for controlling or supporting conception and cleaning or sterilizing medical devices are covered by the definition. Lastly, some products “without an intended medical purpose” that come into contact with the human body are also included in the scope of the regulation.
Examples of products regulated by the EU MDR 2017/745 include:
Implantable devices
Surgical instruments
Dermal fillers and liposuction equipment
Condoms and lubricants
Eyeglasses and contact lenses
Thermometers
Plasters and bandages
Medical software
The MDR does not apply to in vitro diagnostic devices (IVDs), such as pregnancy tests and blood tests. These are covered by Regulation (EU) 2017/746 instead. In borderline cases, guidance documents from the EU Medical Device Coordination Group (MDCG) can be used to assess whether a product should be classified as a medical device or whether it belongs to some other product group, such as IVDs, medicines, food, or cosmetics.2
Medical device classification
The EU MDR classifies medical devices into four categories: I, IIa, IIb, and III. Categorization is based on the intended purpose of the device and the risks associated with its use. The safety and performance requirements are stricter for more invasive devices, and more extensive testing is needed to demonstrate their regulatory compliance.3
Table 1: Overview of device classes under the EU MDR
Class | Risk level | Key criteria | Examples of applicable devices |
Class I | Low | Non-invasive devices, unless specific higher-risk use applies; reusable surgical instruments and invasive devices for transient use (≤60 min) through a body orifice, or short-term use (≤30 days) in the mouth, nose, or ear | Wheelchairs, eyeglasses, stethoscopes, walking aids, hospital beds, plasters and wound dressings for superficial skin or mucous membrane injuries, examination gloves, reusable scalpels |
Class IIa | Medium | Non-invasive devices excluded from Class I; invasive devices for long-term use (>30 days) in mouth, nose, or ear; short-term use in other body orifices; many active diagnostic devices; surgically invasive devices for transient or short-term use | Tubing for infusion pumps, organ transplant containers, anaesthesia breathing circuits, hydrogel dressings, short-term contact lenses, tracheal tubes, dental crowns, needles and syringes, surgical gloves and swabs |
Class IIb | Higher | Devices for modifying human cells/tissues prior to reintroduction; devices in contact with injured skin that heals only by secondary intent; long-term invasive devices used in body orifices other than the mouth, nose, or ear; surgically invasive devices producing ionizing radiation or administering medicines; most implants, unless justified as Class III | Blood bags, dressings for severe wounds (e.g., ulcers, burns), long-term contact lenses, urethral stents, refillable insulin pens, intra-ocular lenses, ventilators, condoms, contact lens storing solutions |
Class III | Highest | Surgically invasive and implantable devices contacting the heart, nervous system, or circulatory system; active implantable devices; devices contacting embryos in vitro prior to administration | Cochlear implants, breast implants, surgical meshes, joint replacements, cardiovascular catheters, spinal needles, prosthetic heart valves |
Safety and performance requirements
Medical devices may only be sold in the EU after they have passed a conformity assessment procedure as described in the MDR. The extent of the assessment depends on the device category, but all devices must meet the general safety and performance criteria, which include the following:4
Establishing and documenting a risk management plan for each device
Implementing a post-market surveillance system
Providing users of the device with adequate information and guidance on safe use
Ensuring that device characteristics and performance are not adversely affected during transport or storage
The chemical, physical, and biological properties of the device must fulfill the following requirements:
Minimized toxicity and flammability of materials and substances
Compatibility with the body and possible medications the device may come into contact with
Mechanical durability
Minimal patient exposure to contaminants and residues
Minimized risk of microbial contamination
Safety of chemical constituents
When devices contain electrical components, the risk of electrical hazards must also be minimized.
Standardized tests for evaluating compliance with the EU MDR
To ensure that the requirements outlined in the previous section are met, medical devices are evaluated against internationally recognized testing standards. The standards themselves are not specified in the MDR, but the European Commission has compiled a summary document on harmonized standards that can be used as safety references.5 Some of these are summarized in Table 1.
Table 2 – Examples of EU harmonized standards for assessing the safety and performance of medical devices
Standard | Topic |
EN ISO 10993-10 | Skin sensitization |
Toxicological risk assessment | |
EN ISO 10993-18 | Chemical characterization |
EN ISO 10993-23 | Skin irritation and intracutaneous reactivity |
Presence of microorganisms | |
Sterilization validation | |
EN ISO 17664-1 | Reprocessing of critical and semi-critical devices |
EN ISO 17664-2 | Reprocessing of non-critical devices |
EN ISO 11607-1 | Requirements for sterile barrier systems and packaging systems |
EN ISO 11607-2 | Validation of forming, sealing, and assembly processes |
Biocompatibility testing for MDR compliance
Even though they are not directly mentioned in the MDR or the summary document, other ISO 10993 standards are generally accepted as the gold standard for evaluating the biocompatibility of medical devices – both in Europe and worldwide. Measurlabs offers a wide range of biocompatibility testing, including the following ISO 10993 tests:
Especially with Class I devices, it is often possible to perform all the required tests (typically parts 18, 5, 10, and 23) with in vitro methods, without any animal testing.
If the medical device incorporates a breathing gas pathway, a further biocompatibility evaluation according to ISO 18562 may also be required.
Other testing services
In addition to biocompatibility evaluations, Measurlabs provides a range of additional medical device testing services to support MDR conformity assessments. The following are just some examples:
We can also support companies with the documentation required for MDR submission, including the biological evaluation plan (BEP) and the biological evaluation report (BER). You can ask for more information and request a quote through the form below. One of our experts will get back to you within one business day.
References
1 Regulation (EU) 2017/745 on medical devices (consolidated version dated 10/01/2025)
2 MDCG guidance documents on regulations (EU) 2017/745 and (EU) 2017/746
3 The classification rules are outlined in detail in Annex VIII of the MDR, with further guidance available at the EU UDI helpdesk website.
4 The detailed safety and performance requirements are outlined in Annex I of the MDR.
5 European Commission’s summary document on harmonized testing standards for medical devices