MDR Article 2(3) defines a ‘custom-made device’ as any device that:
− is 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
− specific design characteristics provided under that person’s responsibility; and
− is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

Examples of CMDs include:
• A dental crown manufactured according to a written prescription provided by a dentist containing specific design characteristics for a particular patient’s individual condition.
• An orthosis made in accordance with a written prescription containing specific design characteristic to aid a person with neuromuscular or musculoskeletal impairment of the lower extremity, such as a Knee Ankle Foot Orthosis (KAFO).
• Hand prosthesis intended to replace a lost body part and/or function made in accordance with a written prescription, where the practionner provides patient specific design characteristics necessary for the manufacturing of the device.
Devices which are not considered CMDs may include:
(a) Devices that are mass-produced which need to be adapted to meet the specific requirements of any professional user, hereafter referred to as adaptable medical devices. (1)
(b) Devices that are mass-produced by means of industrial manufacturing processes, potentially made in accordance with the written prescriptions of an authorised person.

Note 1: Adaptable medical devices (products which fall under (a) above) are mass-produced (2) medical devices which must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions (3) to suit an individual patient’s specific anatomo-physiologic features prior to use.
Examples of mass produced adaptable medical devices may include:

• certain spectacle frames and optical glasses (assembled together to form spectacles).
• patient fitted wheelchairs.
• hearing aids (otoplastic and amplifier).
• orthotic braces.
• exo-prosthetics.

According to MDR art. 16(1), a person (e.g. healthcare professional) who adapts, adjusts,
assembles or shapes an adaptable medical device for a particular patient is not regarded as a
manufacturer, as long as the adaptation, adjustment, assembly and shaping does not modify
the device in such a way that compliance with the applicable requirements may be affected or
changes the intended purpose. (4)
Note 2: Patient-matched medical devices, as defined by IMDRF, (5) are devices which may fall
under point (b) above. A patient-matched device is defined as a medical device that meets the
following requirements:

• it is matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and
• it is typically produced in a batch through a process that is capable of being validated and reproduced; and
• it is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional.

Different from a custom-made device, these devices are typically produced in batches or
through mass production and do not require a written prescription by an authorised person
(see Q6 for more information on written prescriptions).
In particular, a patient-matched medical device is held under the sole accountability of the
manufacturer who is entirely responsible for the design, safety, performance and overall
compliance of the device.

It must be underlined that products which are adaptable medical devices or patient-matched medical devices (as defined by IMDRF) are not qualified as CMDs and must follow the ‘standard’ MDR regulatory pathway for placing on the market.
Examples of patient-matched devices:

• Plates used to fix a broken bone, which are made by 3D printing, based on a template model and DICOM files/ images of the patient. The plates are printed within the validated dimensional ranges allowed by the specified design envelope under the sole responsibility of the manufacturer.
• Cutting guides used in procedures such as knee arthroplasties, or guides used for pedicle screw placement, that are made by 3D printing based on MR or CT data to match a specific patient.
• Mandibular implants produced by a 3D printing manufacturer, from a template model and DICOM files.
• Made to order contact lenses which are produced on request typically in batches with validated or verified production processes using standardised tools and materials and within clearly specified dimensions. No specific or individual design process necessary.
• An externally worn orthosis to support, prevent or assist body functions, based on external 3D scan images and or measures, by a manufacturer who produces this under his sole responsibility, within validated parameters.

In accordance with Article 2(1) MDR, the intended purpose of a medical device can be achieved
either alone or in combination with other devices or products. Certain parts, components or
materials may carry a medical intended purpose and can thus fulfil the definition of a medical
device. By analogy, parts, components or materials of custom-made devices, adaptable medical
devices or patient-matched medical devices may be CE-marked medical devices.
Accordingly, it is possible for “intermediate products” which are specifically intended for the
manufacture of CMDs, adaptable medical devices or patient-matched medical devices to be
also placed on the market as medical devices, as these products are specifically intended to
become a part or component of a final CMD, adaptable medical device (finally adapted) or
patient-matched medical device. (6) Instructions for use provided by the manufacturer of these
CE marked devices should be followed when performing further preparatory processing,
preparation, configuration, installation, assembly, adaptation or fitting in order to meet the
needs of the user or patient prior to their use.

‘Accompanying documentation‘ containing the importer’s details, may be separate from or affixed to the individual device, as long as it accompanies the individual device throughout the supply chain and reaches the end user. The accompanying documentation should allow the importer to be located and contacted (Article 13(3) of the Regulations) and allow healthcare professionals, patients or users to report suspected incidents (Article 13(8) of the Regulations) to the importer. The importer may choose the appropriate accompanying documentation, as long as it reaches the end user. Examples may include a sticker affixed to the label or a leaflet.

Where any additional label is used to provide the importer’s information, it should not obscure the information on the label provided by the manufacturer in accordance with Annex I 23.2 MDR/Annex I 20.2 IVDR.

It is also noted that the distributor may not sell products where documentation or the importer’s information is missing (see Article 14(2)(c) of the Regulations). 

Not normally. Some 3PL companies which provide transportation services or hold devices on a consignment basis only (i.e. where devices are held at a site by the 3PL, but the 3PL does not have legal ownership of those devices), may not be considered an importer provided there is a clearly defined agreement between both parties setting out the responsibilities of each party (1). The importer is the natural or legal person meeting the definition of Article 2(33) MDR/Article 2(26) IVDR, with ownership, possession or any other property right over the device. That party is required to affix their details to the device, label or accompanying documentation in accordance with Article 13(3) of the Regulations. Although transportation or storage activities may be subcontracted outside of the importer’s organisation, the importer retains responsibility over storage and transport conditions and as such, must ensure the sub-contractor’s conditions do not jeopardise compliance with the general safety and performance requirement of Annex I of the Regulations (see Article 13(5) of the Regulations).

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(1) Please also note that ‘Fulfilment service providers’ as defined in Article 3(11) of Regulation (EU) 2019/1020 on market surveillance are now considered economic operators under that Regulation 2019/1020 and should meet any associated obligations. A ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council (31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (32), and any other postal services or freight transport services. See also, Commission Notice on the market surveillance of products sold online Text with EEA relevance. (europa.eu))

Not normally. Transportation is not a distribution activity and therefore a 3PL conducting transportation only, even if this includes short term in transit storage to facilitate transportation, would not be considered a distributor (1). The distributor is the person with ownership, possession or any other right over the device, who meets the definition provided for in Article 2(34) MDR/Article 2(27) IVDR (i.e. making available on the market up until the point of putting into service). Although transportation or storage activities may be subcontracted outside of the distributor’s organisation, the distributor in accordance with Article 14(3) of the Regulations shall ensure that while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.

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(1) Please also note that ‘Fulfilment service providers’ as defined in Article 3(11) of Regulation (EU) 2019/1020 on market surveillance are now considered economic operators under that Regulation 2019/1020 and should meet any associated obligations. A ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council (31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (32), and any other postal services or freight transport services. See also, Commission Notice on the market surveillance of products sold online Text with EEA relevance. (europa.eu))

Importers and distributors have the obligation to verify whether the requirements mentioned in Article 13(2) MDR and 14(2) of the Regulations, are met before making the device available on the market. Moreover, if an importer or distributor considers or has reason to believe that devices are not in conformity with the MDR, they have the obligation to inform relevant parties (manufacturers and where applicable authorised representatives or importers) and to not make these devices available.
For distributors, the verification checks mentioned in Article 14(2) subparagraphs (a), (b) and (d) of the Regulations might be done based on a sampling method representative of the device supplied, except for the Article 14(2)(c) checks on imported devices.

Yes. In accordance with Article 14(2) of the Regulations the distributor is required to inform the competent authority (of the Member State in which it is established) if they believe the device presents a serious risk or is falsified (1). General complaints not meeting the definition of a serious risk or a falsified device however, are not reportable. Article 14(6) of the Regulations outlines that distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. In addition, under Article 14(6) of the MDR distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.

For importers, the above also applies (Article 13(7) of the Regulations). Where the device presents a serious risk, importers have the additional obligation to inform the notified body that issued the device certificate, if applicable. The importer should in such cases give details, in particular, of the non-compliance and of any corrective action taken.

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(1) Please see the Commission website for the list of member state competent authorities for medical devices.

Yes. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer (Article 14(5) of the Regulations). Distributors should keep a register of complaints of non-conforming devices, recalls and withdrawals and keep the manufacturer, and where available the authorised representative and importer, informed of such monitoring. They should also provide manufacturers with any information upon their request (Article 14(5) of the Regulations).
Importers also have related obligations regarding reports and registry of complaints and non-conforming devices in accordance with Article 13(6) and 13(8) of the Regulations.

For ‘legacy devices’, the obligations outlined in Articles 13 and 14 of the MDR should be read in conjunction with the transitional provisions in Article 120(3) MDR for such devices. Some of these obligations, serving to support a well-functioning vigilance and market surveillance system as well as proper registration of economic operators and devices, therefore apply. These include in particular, for importers Article 13(2), last paragraph, (4), (6)-(8), (10) MDR related to reporting and cooperation and for distributors, Article 14(2), last subparagraph,(4)-(6). However, verification obligations related to labelling and UDI Requirements established under the Regulation do not apply.

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(1) Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(2) For further information on ‘legacy devices’ please see MDCG 2021-25 ‘Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC’.