According to the MDR, a medical device may be placed on the market or put into service only if it complies with the MDR.[1] One of the MDR requirements are that a medical device considered to be in conformity with the requirements of the MDR shall bear the CE marking of conformity. The CE mark must be affixed before the medical device is placed on the market.[2]
The EU Member States have laid down rules regarding penalties applicable for acting contrary to the MDR. For instance, under Dutch law, not affixing a CE mark before marketing a device can lead to an administrative fine or an order subject to penalty.[3] Depending on the risk to the health or safety of patients, users or other persons, Member State supervisory authorities have additional means of enforcement following from the MDR, potentially leading up to a product recall and/or sales ban.[4]
However, in some cases, a medical device does not need a CE mark in order to be used legally.
What is an investigational device?
A device that is assessed in a clinical investigation (“Investigational Device”) does not need to bear a CE mark.[5] Investigational devices are however subject to the requirements set out in Articles 62 to 80 and 82 of the MDR regulating clinical investigations including general safety and performance requirements regarding aspects of the device that are not covered by the clinical investigation. In principle, investigational devices may only be used by patients participating in a clinical investigation. [see also: How do I approach clinical evaluation including contact with hospitals?]
What is a custom-made device?
A device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs (“Custom-made device”) does not need to bear a CE mark.[6] That being said, manufacturers of custom-made devices do need to comply with the procedure set forth in Annex XIII of the MDR regarding information, documentation, manufacturing and post-market clinical follow-up requirements. Even more rules apply to custom-made implantable devices.[7]
What is in-house development?
Devices, manufactured and used only within health institutions that are not manufactured on an industrial scale, are exempted from the provisions laid down in the MDR (including affixing a CE mark) except for Annex I on general safety and performance requirements if certain conditions are met.[8] One such condition is the restriction to not transfer the device to another legal entity. Detailed guidance on these conditions is provided by the Medical Device Coordination Group.[9]
What about compassionate use (article 59 derogation)?
Before placing a device on the market or putting it into service (and legally affixing a CE mark), manufacturers need to undertake a conformity assessment procedure.[10] However, according to Article 59 of the MDR, a competent authority may authorise the placing on the market and putting into service of a specific device for which the conformity assessment procedure has not been carried out, when there is a duly justified request and the use of the device is in the interest of public health or patient safety or health. In the Netherlands, the competent authority is the Healthcare and Youth Inspectorate (IGJ). If the derogation is not limited to a single patient, the Member State authority must inform the Commission and the other Member States.[11] Please note that a derogation based on Article 59 MDR is granted in exceptional cases.
[1] Art. 5(1) MDR.
[2] Art. 20(1 and 4) MDR.
[3] Art. 12 and 14 Dutch Medical Device Act (“Wet medische hulpmiddelen”).
[4] See for more information Art. 93-98 MDR.
[5] Art. 20(1) MDR.
[6] Ibid. Please note that mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person are not considered to be custom-made devices. For more guidance, see MDCG 2021-3: Questions and Answers on Custom-Made Device.
[7] Art. 52(8) MDR.
[8] Art. 5(5) MDR.
[9] MDCG 2023-1, Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[10] Art. 52 MDR.
[11] Further information about ‘due justification’ can be found in the ‘Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C171/01)’.
