The new European Union Medical Device Regulation (EU) 2017/745 was published in April 2017 and became fully applicable in May 2021. The regulation1 sets out strict safety and quality standards for medical devices, the fulfillment of which requires third-party lab testing. Manufacturers and importers must meet these requirements to market their products within the member states.
Measurlabs offers a comprehensive range of medical device testing services from biocompatibility to microbiological cleanliness and sterility. Do not hesitate to contact us to discuss the testing options for evaluating your device’s compliance with the EU MDR.
Which devices does the EU MDR 2017/745 cover?
In Article 2(1) of the MDR Regulation, 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 fillings and liposuction equipment
Condoms and lubricants
Eyeglasses and contact lenses
Thermometers
Plasters and bandages
Medical software
The regulation 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 certain cases, it may be difficult to determine whether a specific product is a medical device, or whether it belongs to some other product category, such as IVDs, medicines, food, or cosmetics. The EU Medical Device Coordination Group (MDCG) provides guidance documents2 that can be used to assess whether a product should be classified as a medical device in such borderline cases.
Categorization of medical devices
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 compliance3.
Class I (low-risk devices) contains wheelchairs, glasses, stethoscopes, and other non-invasive medical devices, unless they are used for specific purposes that increase the risks of use. Reusable surgical instruments and invasive devices that are used through a body orifice are also classified into class I if they are intended for transient use (up to 60 minutes at a time) or if they are meant for short-term use (up to 30 days) inside the mouth, nose, or ear.
Class IIa (medium-risk devices) covers many of the non-invasive devices excluded from class I, such as most devices intended for channeling body fluids and managing the micro-environment of injured skin. Class IIa also includes invasive devices intended for long-term use (more than 30 days) in the mouth, nose, or ear or short-term use in other body orifices. Dental crowns, some active diagnostic devices, and many surgically invasive devices intended for transient or short-term use also belong to class IIa.
Class IIb (higher-risk devices) includes blood bags and non-invasive devices intended for modifying human cells and tissues before their reintroduction into the body. Devices in contact with injured skin belong to class IIb if the wound can only heal by secondary intent. Invasive devices in class IIb include ones used in body orifices other than the mouth, nose, or ear for an extended period and surgically invasive devices that produce ionizing radiation or are intended for administering medicines. Implantable devices belong to class IIb unless their risk profile justifies placement in class III.
Class III (highest-risk devices) contains the most high-risk devices, such as surgically invasive and implantable devices that come into direct contact with the heart, nervous system, or circulatory system. Class III also includes active implantable devices, breast implants, surgical meshes, joint replacements, and substances that come into contact with human embryos in vitro before their administration into the body.
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 criteria4, which include the following:
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
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 document5 on harmonized standards that can be used as safety references. Some of these are summarized in Table 1.
Table 1 – Examples of harmonized tests for assessing the safety and performance of medical devices
Standard | Assessed parameter |
EN ISO 10993-10 | Skin sensitization |
EN ISO 10993-23 | Skin irritation |
Presence of microorganisms | |
Sterilization |
Even though they are not mentioned in the regulations 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 above tests with in vitro methods, without any animal testing.
We can also prepare the biological evaluation plan (BEP) for your product. 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
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.
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