Acessibilidade

According to Article 2(1) of Regulation (EU) 2017/745 (MDR), a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

•     Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
•     Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
•     Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
•     information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

The principal intended action of a medical device is not achieved by pharmacological, immunological or metabolic means, although its function may be assisted by such means.

The following products shall also be deemed to be medical devices:

•      devices for the control or support of conception;
•      products specifically intended for the cleaning, disinfection or sterilisation of devices.

The MDR also applies to certain products without an intended medical purpose, listed in Annex XVI.

According to Article 2(4) of Regulation (EU) 2017/745, an active device is any device whose operation depends on a source of energy other than that generated by the human body for that purpose or by gravity, and which acts by changing the density of or converting that energy.

Software is also considered an active device where it meets the definition of a medical device.

Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, are not considered active devices.

According to Article 2(45) of Regulation (EU) 2017/745, a clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

An investigational device is a device that is assessed in a clinical investigation.

If the device is intended for clinical investigation only, the label shall bear the statement "exclusively for clinical investigation".

Clinical investigations in Portugal are subject to the applicable authorisation and notification procedures involving INFARMED, I.P., and the relevant ethics committee.

More information (PT page).

According to Article 2(3) of Regulation (EU) 2017/745, a custom-made device is any device specifically made in accordance with a written prescription issued by a 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 to meet their individual conditions and needs.

Mass-produced devices which are adapted to meet the specific requirements of a professional user, and devices manufactured in accordance with written prescriptions within the mass production process, are not considered custom-made devices.

Custom-made devices must comply with the applicable requirements of the MDR, including those laid down in Annex XIII.

According to Article 2 (10 & 11) of Regulation (EU) 2017/745:

•  A procedure pack is a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
•  A system is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

The persons responsible for combining devices and other products into a system or procedure pack must comply with Article 22 of the MDR.

Where the conditions laid down in Article 22 are met, the person responsible for combining the products must draw up the relevant statement and comply with the applicable requirements.

The qualification of a product as a medical device depends on its intended purpose, as defined by the manufacturer, and on the definition laid down in Article 2(1) of Regulation (EU) 2017/745.

The qualification must take into account the product's intended purpose, its characteristics, its principal mode of action and the applicable provisions of the MDR.

Certain products without an intended medical purpose are also covered by the MDR and are listed in Annex XVI.

The classification of a product as a medical device or another type of product must be assessed on a case-by-case basis, taking into account the applicable European Union legislation and guidance.

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The manufacturer is responsible for ensuring that the device complies with the applicable regulatory requirements before it is placed on the market.

The importer is responsible for placing on the Union market a device from a third country and must fulfil the obligations laid down in Article 13 of Regulation (EU) 2017/745.

Distributors make devices available on the market and must comply with the obligations laid down in Article 14 of the MDR.

The distributor must verify, among other things, that the device bears the CE marking, that the required information accompanies the device.

According to Article 2(30) of Regulation (EU) 2017/745, a manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

The manufacturer is responsible for ensuring that the device complies with the applicable requirements of the MDR, including the requirements concerning the design, manufacture, conformity assessment, technical documentation, clinical evaluation and post-market surveillance.

The manufacturer's obligations are laid down in Article 10 of the MDR.

According to Article 2(32) of Regulation (EU) 2017/745, an authorised representative is a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the European Union to act on the manufacturer's behalf in relation to specified tasks concerning the manufacturer's obligations under the MDR.

Manufacturers established outside the European Union must appoint an authorised representative in accordance with Article 11 of the MDR.

According to Article 51 of Regulation (EU) 2017/745, medical devices are classified into four classes according to their intended purpose and the risks associated with their use:

• Class I – low risk;
• Class IIa – medium risk;
• Class IIb – medium/high risk;
• Class III – high risk.

The classification rules are set out in Annex VIII of the MDR.

The classification depends on factors such as the duration of use, whether the device is invasive or non-invasive, whether it is implantable, and the part of the body with which it interacts.

The manufacturer is responsible for determining the risk classification of the device in accordance with the applicable classification rules.

The classification criteria are established in Annex VIII of Regulation (EU) 2017/745.

The classification depends on the intended purpose of the device and on the risks associated with its use. The applicable rules take into account, among other factors:

• The duration of use: transient, short-term or long-term;
• Whether the device is invasive or non-invasive;
• Whether the device is implantable;
• The anatomical site with which the device interacts, including the central circulatory system and central nervous system;
• Whether the device is active and, where applicable, its intended function;
• Other specific characteristics and risks addressed by the classification rules.

The manufacturer must apply the relevant classification rules and document the rationale for the classification assigned to the device.

The CE marking indicates that the device complies with the applicable requirements of Regulation (EU) 2017/745.

Before affixing the CE marking, the manufacturer must carry out the applicable conformity assessment procedure, draw up the EU declaration of conformity and ensure that all relevant regulatory requirements have been fulfilled.

Where required, a notified body must be involved in the conformity assessment procedure.

The CE marking must be affixed in accordance with Article 20 of the MDR.

Custom-made devices and devices intended for clinical investigation do not bear the CE mark.

A medical device bearing the CE marking must comply with the applicable general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745.

In particular:

• The device must be suitable for its intended purpose as specified by the manufacturer.
• It must achieve the performance intended by the manufacturer.
• It must be designed and manufactured so that its use does not compromise the health or safety of patients, users or other persons, provided that any risks associated with its use are acceptable when weighed against the benefits to the patient.
• The risks associated with the device must be reduced as far as possible without adversely affecting the benefit-risk ratio.
• The information supplied with the device, including the labelling and instructions for use, must be appropriate to ensure its safe and proper use.

The device must continue to meet the applicable safety and performance requirements throughout its expected lifetime.

Where a notified body is involved in the conformity assessment procedure, its four-digit identification number must appear alongside the CE marking.

The number identifies the notified body responsible for the relevant conformity assessment activities.

The involvement of a notified body depends on the device's classification and the applicable conformity assessment procedure.

For example, under the MDR, notified body involvement is required for Class IIa, IIb and III devices, as well as for certain Class I devices, namely sterile devices, devices with a measuring function and reusable surgical instruments.

According to Article 2(42) of Regulation (EU) 2017/745, a notified body is a conformity assessment body designated in accordance with the MDR.

Notified bodies are designated by the national authorities responsible for notified bodies following an assessment of their compliance with the requirements laid down in the MDR and are subject to monitoring and surveillance.

Their main responsibilities include:

• Carrying out conformity assessment procedures in accordance with the MDR;
• Assessing the manufacturer's quality management system and technical documentation, as applicable;
• Issuing, suspending, restricting, withdrawing or refusing conformity assessment certificates;
• Conducting appropriate surveillance activities;
• Cooperating with competent authorities and other notified bodies.

Notified bodies are identified by a four-digit number and their designation and scope of designation can be consulted in the European Commission's NANDO database.

INFARMED – National Authority of Medicines and Health Products, I.P. – is the Portuguese competent authority for medical devices covered by Regulation (EU) 2017/745.

In accordance with Decree-Law No. 29/2024 of 5 April, Infarmed is responsible for monitoring and enforcing compliance with the MDR and the applicable national legislation.

Its responsibilities include market surveillance, vigilance, the supervision of economic operators and the protection of public health and safety.

In accordance with Regulation (EU) 2017/745 and Decree-Law No. 29/2024, INFARMED's responsibilities include:

• Monitoring and enforcing compliance with the applicable European Union and national legislation;
• Carrying out market surveillance activities and adopting the necessary measures where non-compliance or risks are identified;
• Authorising clinical investigations and supervising the relevant investigation sites, in accordance with the applicable legislation;
• Monitoring the safety and performance of medical devices placed on the market;
• Receiving and assessing reports of suspected serious incidents;
• Adopting the necessary measures to protect public health and patient and user safety;
• Supervising notified bodies and exercising the responsibilities assigned to it as the national authority responsible for notified bodies;
• Cooperating with other national and European competent authorities and participating in European Union activities concerning medical devices.

The manufacturer is responsible for ensuring that the device complies with the applicable general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745.

Before placing a device on the market, the manufacturer must carry out the applicable conformity assessment procedure in accordance with Article 52 of the MDR.

Depending on the device's classification and the applicable procedure, the involvement of a notified body may be required.

For Class I devices, other than those requiring notified body involvement because they are sterile, have a measuring function or are reusable surgical instruments, the manufacturer may carry out the conformity assessment without the involvement of a notified body.

Custom-made devices are subject to the specific requirements laid down in Article 52(8) and Annex XIII of the MDR.

Systems and procedure packs must comply with Article 22 of the MDR.

The documents relevant to demonstrating conformity depend on the classification of the device and the applicable conformity assessment procedure.

They may include:

• The EU declaration of conformity drawn up by the manufacturer in accordance with Article 19 and Annex IV of Regulation (EU) 2017/745;
• The certificate (or certificates) issued by the notified body, where its involvement is required;
• The technical documentation and other supporting documents demonstrating compliance with the applicable regulatory requirements.

The EU declaration of conformity is drawn up and signed by the manufacturer, who assumes responsibility for compliance with the MDR.

The presence of a notified body certificate does not replace the manufacturer's responsibility for the conformity of the device.

Custom-made devices are subject to the specific documentation requirements laid down in Annex XIII of the MDR and do not bear the CE marking.

Certificates issued by notified bodies under Regulation (EU) 2017/745 must comply with the applicable requirements laid down in Article 56 and Annex XII of the MDR.

Depending on the applicable conformity assessment procedure, a certificate should include, in particular:

• The name and identification number of the notified body;
• The name and address of the manufacturer;
• Identification of the devices covered by the certificate;
• The applicable conformity assessment procedure;
• The relevant regulatory references;
• The date of issue;
• The period of validity, where applicable;
• The certificate identification number.

The validity and scope of a certificate should be verified with the issuing notified body and, where applicable, through the information available in the relevant European databases.

The manufacturer must follow the conformity assessment procedure applicable to the device's classification, in accordance with Article 52 of Regulation (EU) 2017/745.

The available procedures are set out in Annexes IX, X and XI of the MDR.

Class I devices

For Class I devices, the manufacturer may carry out the conformity assessment procedure under its sole responsibility, without the involvement of a notified body, except where the device is sterile, has a measuring function or is a reusable surgical instrument.

In those cases, the involvement of a notified body is limited to the aspects specified in Article 52(7) of the MDR.

Class IIa devices

For Class IIa devices, the manufacturer must involve a notified body in accordance with Article 52(6) of the MDR.

The applicable conformity assessment procedures are set out in Annexes IX, X and XI.

Class IIb devices

For Class IIb devices, the manufacturer must involve a notified body in accordance with Article 52(6) of the MDR.

The applicable conformity assessment procedures are set out in Annexes IX, X and XI.

Class III devices

For Class III devices, the manufacturer must involve a notified body in accordance with Article 52(4) of the MDR.

The applicable conformity assessment procedures are set out in Annexes IX, X and XI, subject to the specific requirements applicable to this class.

Custom-made devices

Custom-made devices are subject to the specific requirements laid down in Article 52(8) and Annex XIII of the MDR.

The manufacturer must draw up the statement referred to in Annex XIII and comply with the applicable requirements.

Custom-made devices do not bear the CE marking.

Devices intended for clinical investigation

Devices intended for clinical investigation must comply with the requirements laid down in Articles 62 to 82 and Annex XV of the MDR, as applicable.

They must bear the indication "exclusively for clinical investigation" and do not bear the CE marking.