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Manual on borderline and classification for medical devices under
Regulation (EU) 2017/745 on medical devices and
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Version 3 – September 2023 | The views expressed in this document represent the agreements reached by the competent
authorities of the Member State members of the Borderline and Classification Working Group, a
subgroup of the Medical Device Coordination Group. The views are not legally binding as only
the Court of Justice of the European Union can... | null | null |
Introduction and scope | Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of the authorities of the Member
States where the product is on the market. However, when different interpretations of EU
legislation occur, public health may be ... | null | null |
1. Regulation (EU) 2017/745 on medical devices | null | null | null |
1.1. Qualification of medical devices | The respective sections will be populated when cases are finalised under the Helsinki Procedure. | null | null |
1.1.1. Borderline between medical devices and IVDs | This section covers the borderline between products that may fall under the MDR or under the
IVDR, where the conclusion is that the product should be qualified as a medical device. | null | null |
1.1.2. Borderline between medical devices and medicinal products, including advanced
therapy medicinal products (ATMPs) | This section covers the borderline between products that may fall under the MDR, or possibly
under Directive 2001/83/EC on the Community code relating to medicinal products for human
use, or under Regulation (EC) No 726/2004 laying down Community procedures for the
authorisation and supervision of medicinal products fo... | null | null |
1.1.2.1 Nasal spray with antibodies for COVID-19 | null | The spray contains antibodies that inactivate the SARS-CoV-2 virus and, as a result, the virus is
no longer able to reproduce and enter mucosal cells. The antibodies, obtained from the colostrum
of infected cows, are sprayed into the human nose where they can attach to the viruses and
inactivate them. | According to the information provided by the manufacturer, the principal intended action of the
spray is achieved through antibodies binding to the virus. As a result, the virus is no longer able
to reproduce and enter mucosal cells.
Considering the product’s principal mode of action and that a medical device cannot ac... |
1.1.2.2 Graphite crucible | null | The product is a graphite crucible used in conjunction with the radionuclide Technetium-99m
(Tc-99m) for imaging the airways (lung ventilation scintigraphy). The graphite crucible is made
of pure carbon and is intended for the preparation of the aerosol.
The resulting aerosol is an ultra-fine dispersion of nanosized pu... | According to Article 1 (6) of Directive 2001/83/EC, radiopharmaceutical is: “Any medicinal
product which, when ready for use, contains one or more radionuclides (radioactive isotopes)
included for a medicinal purpose.”
According to Article 1 (8), a kit is: “Any preparation to be reconstituted or combined with
radionucl... |
1.1.2.3 Product for professional removal of dental biofilm | null | Qualification of a product for professional removal of dental biofilm/plaque, consisting of a
syringe prefilled with TiO2 + polymer (inert) and a vial of hydrogen peroxide (H2O2): The H2O2
shall be mixed with the content of the syringe before use, resulting in a gel that is applied by the
syringe on to the teeth’s in t... | The product has a medical intended purpose based on claims regarding attenuation of
inflammation - gingivitis, periodontitis and peri-implantitis. However, the antimicrobial action of
ROS, which is considered as the principal intended action, should be considered
pharmacological, immunological or metabolic mode of acti... |
1.1.2.4 Root canal irrigation solution | null | Two root canal irrigating solutions intended to be used in endodontic treatment are placed on the
market as medical devices consisting of sodium hypochlorite (NaOCl) 3% aqueous solution for
canal irrigation and another solution with chlorhexidine digluconate (CHX) 2% root canal
solution for final irrigation and debride... | Sodium hypochlorite (NaOCl) and chlorhexidine (CHX) are substances which have
antimicrobial properties. NaOCl has an antimicrobial action and has the ability to dissolve
biofilm components. CHX is an active ingredient of many approved medicinal products.
Both substances are medicinal substances with known pharmacologic... |
1.1.3. Borderline between medical devices and biocides | This section covers the borderline between products that may fall under the MDR or possibly
under Regulation (EU) No 528/2012 concerning the making available on the market and use of
biocidal products. | null | null |
1.1.3.1 Substance for textile treatment | null | The product is a concentrate for water-based treatment of textile materials to impart antifungal,
antimicrobial and antiviral properties in various applications.
The intended purpose is the prevention of human infectious diseases caused by microorganisms
spread through contact with surfaces, especially textile ones. Th... | This product does not act on individual patients, rather, it imparts antifungal, antimicrobial and
antiviral properties onto textiles. Based on the information provided by the manufacturer this
product should not be qualified as a medical device. |
1.1.4. Borderline between medical devices and substances of human origin | This section covers the borderline between products that may fall under MDR or possibly under
Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement,
testing, processing, preservation, storage and distribution of human tissues and cells or Directive
2002/98/EC on blood and blood c... | null | null |
1.1.5. Borderline between medical devices and cosmetic products | This section covers the borderline between products that may fall under the MDR or possibly
under Regulation (EC) No 1223/2009 on cosmetic products. | null | null |
1.1.6. Borderline between medical devices and food | This section covers the borderline between products that may fall under MDR on medical
devices or possibly under Regulation (EC) 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety. | null | null |
1.1.7. Borderline between medical devices and personal protective equipment | This section covers the borderline between products that may fall under the MDR or possibly
under Regulation (EU) 2016/425 on personal protective equipment. | null | null |
1.1.7.1 Rescue bag for patient transport | null | The rescue bag is designed for the transportation of patients during rescue operations. According
to the manufacturer, the product is intended to protect the patient mechanically, as well as
thermally, during the salvage. The mechanical protection of the head is ensured by additional
padding in the head area. To stabil... | The product in question enables stable and protected transport of patients in order to avoid the
worsening of their state of health. The intended purpose of the product corresponds to the
medical purpose of alleviation of, or compensation for, an injury or disability, according to Art.
2(1) of the MDR. It should be the... |
1.1.7.2 Plexiglas box for caregiver protection | null | The product is a safety box intended to prevent caregivers from being exposed to infection (i.e.
COVID-19) by containing droplets expelled by the patient during endotracheal intubation,
tracheotomy or any airway related procedure.
The box is intended to be placed over the patient’s head, covering the upper body from he... | A medical device has the aim to provide protection of health and safety of the patient. An
intended medical use may not be defined when the product is primarily intended to protect the
caregiver or health care professional.
A product solely intended to protect a caregiver or health care professional by preventing
expos... |
1.1.8. Borderline between medical devices and general consumer products | This section covers the borderline between products that may fall under the MDR or possibly
under Directive 2001/95/EC on general product safety. | null | null |
1.1.9. Other medical device borderlines | null | null | null |
1.1.9.1 Smartphone application for STI prevention strategies | null | This application is intended by the manufacturer to “prevent sexually transmitted infections
(STIs), by allowing for the exchange of information between different sexual partners.”
It permits the recording of biological analysis results, like STI results, in order to share this
information with other potential sexual p... | The application transmits and exchanges data and information between partners. On this basis
alone, the software would not perform an action on data other than communication, as per in
MDCG 2019-11. The application does not prevent sexually transmitted diseases, but rather
facilitates the exchange of information and co... |
1.1.9.2 Medical calculators | null | The intended purpose of a medical calculator is to facilitate one or more (sometimes up to 400)
routine medical calculations at the point of care for multiple clinical disciplines by means of an
app or webpage.
Calculation methods incorporated in the medical calculator are taken from or based on formulas
or tables docu... | Calculation of a score according to a specific formula or an complex algorithm as mentioned in
both examples is an action on data beyond the use of simple search as referenced in qualification
decision step 3 of MDCG 2019-11 (“Decision steps for qualification of software as MDSW”).
Also, the calculation is for the bene... |
1.1.9.3 Needle Counters | null | There are on the market products generally called needle counters, intended to allow the
counting and to reconcile the count of suture needles and scalpels, after the procedure and before
suturing the operating cavity. These needle counters are designed to facilitate the control of such
small instruments. Some of the m... | Needle counters, intended to allow the counting and reconciling the count of suture needles and
scalpels, as well as their elimination, after the procedure and before suturing the operating cavity,
do not comply with the legal definition of a medical device, according to Article 2 (1) of the
MDR, since they are not int... |
1.1.9.4 Temperature sensors embedded in orthopaedic devices for compliance tracking | null | The product in question is a temperature sensor that is intended to be embedded in orthopaedic
devices, for example scoliosis braces. It then tracks the use of the orthopaedic device, which are
typically not very comfortable but have to be worn daily for long periods of time to be effective.
This is done by regularly m... | According to Article 2 (2) of the MDR, ‘accessory for a medical device’ means an article which,
whilst not being itself a medical device, is intended by its manufacturer to be used together with
one or several particular medical device(s) to specifically enable the medical device(s) to be used
in accordance with its/th... |
1.1.9.5 System intended to produce sclerosing foam | null | The system is intended to produce sclerosing foam for varicose veins treatment. It consists of
two products to be used in combination: a sterile single use mixing capsule filled with air or with
a mixture of gases (O2/CO2 equal parts), which has a port for the introduction of the sclerosing
agent (medicinal product) an... | This system is intended by its manufacturer to just produce, in an on-the-spot manner, the
sclerosing foam, which is considered a medicinal product, and that is going to be introduced
afterwards in the body by a syringe which is not part of the system.
In this case, as neither the system itself nor the capsule or the s... |
1.2. Classification of medical devices | The respective sections will be populated when cases are finalised under the Helsinki Procedure. | null | null |
1.2.1. Rule 1 | null | null | null |
1.2.1.1 Rescue bag for patient transport | See entry 1.1.7.1. | null | null |
1.2.7. Rule 7 | null | null | null |
1.2.7.1 Dermal filler implantable | null | Dermal fillers are usually devices intended to be used for aesthetic purposes included in the
annex XVI to the MDR. These devices are injected into the skin with a syringe, at different
depths, to help fill in facial wrinkles and provide facial volume. Most of these wrinkle fillers are
temporary (not permanent) because... | Dermal fillers which are wholly or mainly absorbed, are covered by rules 7 and 8 of Annex VIII
to the MDR, depending on the intended duration of use.
As they are administered by injection, and this is considered a clinical intervention, they fulfil
the definition of an implantable device, according to Article 2(5) of t... |
1.2.8. Rule 8 | null | null | null |
1.2.8.1 Dermal filler implantable | See entry 1.2.7.1. | null | null |
1.2.8.2 n-butyl-2-cyanoacrylate based adhesives | null | The products are n-butyl-2-cyanoacrylate (nBCA) based adhesives that close the treated vessel
via an adhesive seal. The products are intended for the permanent and complete endovascular
adhesive closure of the great saphenous vein (GSV) and associated varicosities when treating
venous reflux disease.
Different manufact... | Third indent of rule 8 of Annex VIII to the MDR states that: “All implantable devices and long-
term surgically invasive devices are classified as class IIb unless they […] – have a biological
effect or are wholly or mainly absorbed, in which case they are classified as class III.”
According to MDCG 2021-24 guidance: “... |
1.2.8.3 Custom-made cranial implant | null | The product is a custom-made cranial implant that functions as a replacement for parts of the
skull. It will be specifically made for a patient to replace parts of the skull in order to protect the
brain from the environment.
The intended use of a custom-made skull implant requires that it is placed on the dura mater. ... | In a normal situation when the cranium is anatomically intact, the outer layer of the meninges,
the dura mater, touches the skull. A medical device that acts as a replacement of the skull will
therefore come into contact with the dura mater as well. According to point 2.7 of Annex VIII to
the MDR, the brain, meninges a... |
1.2.9. Rule 9 | null | null | null |
1.2.9.1 Argon coagulation units | null | These units are used in argon plasma coagulation, a monopolar electrosurgical technique where
the argon plasma takes the role of the application electrode, which makes the intervention using
this technique contactless.
The argon coagulation unit ensures the delivery and controlled flow of argon to the argon
electrode. ... | Due to their intended use, i.e. to enable the argon plasma coagulation and the dependence on an
electrical energy source, argon coagulation units are active therapeutic devices. Argon
coagulation units directly influence the argon plasma coagulation where the electrical energy is
administered to the body tissues by the... |
1.2.11. Rule 11 | null | null | null |
1.2.11.1 Medical calculators | See entry 1.1.9.2 | null | null |
1.2.14. Rule 14 | null | null | null |
1.2.14.1 Root canal irrigation solution | See entry 1.1.2.4 | null | null |
1.2.16. Rule 16 | null | null | null |
1.2.16.1 Ethylene oxide gas cartridges | null | Ethylene oxide (EtO) gas is a sterilant. The product in question is a single-use cartridge
containing 100% EtO. The intended use for these cartridges is to sterilise and disinfect medical
devices.
An EtO gas sterilisation cycle consists of five steps: preconditioning and humidification, gas
introduction, exposure, evac... | Rule 16 of the Regulation (EU) 2017/745 states that “[…] All devices intended specifically to be
used for disinfecting or sterilising medical devices are classified as class IIa, unless they are
disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting
invasive devices, as the end ... |
null | null | null | null |
2. Regulation (EU) 2017/746 on in vitro diagnostic medical devices | null | null | null |
2.1 Qualification of IVDs | The respective sections will be populated when cases are finalised under the Helsinki Procedure. | null | null |
2.1.1. Borderline between IVDs and medical devices | This section covers the demarcation between products that may fall under the IVDR or under the
MDR, where the conclusion is that the product should be qualified as an IVD. | null | null |
2.1.1.1 FeNO measuring device | null | The product is intended by its manufacturer to be used for the measuring of fractional exhaled
Nitric Oxide (FeNO). NO is a gas produced by cells involved in the inflammation associated
with allergic or eosinophilic asthma. The NO is exhaled, meaning that the NO level, which is
related to the occurrence of some disease... | The exhaled air is no longer part of the human body and therefore the exhaled air is considered
to be a gaseous specimen derived from the human body, which is subsequently analysed by a
device outside of the body. The device provides information for a medical purpose concerning a
physiological or pathological state, wh... |
2.1.2. Borderline between IVDs and general laboratory equipment | null | null | null |
2.1.3. Other IVD borderlines | null | null | null |
2.2 Classification of IVDs | The respective sections will be populated when cases are finalised under the Helsinki Procedure. | null | null |
2.2.1. Rule 1 | null | null | null |
2.2.2. Rule 2 | null | null | null |
2.2.3. Rule 3 | null | null | null |
2.2.4. Rule 4 | null | null | null |
2.2.5. Rule 5 | null | null | null |
2.2.6. Rule 6 | null | null | null |
2.2.7. Rule 7 | null | null | null |
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