Frequently Asked Questions on Medical Devices in Portugal

1. Overview

INFARMED, I.P., the Portuguese authority for medical devices, provides a comprehensive set of FAQs covering definitions, classifications, responsibilities, and regulatory processes under Law-Decree nº 145/2009 of 17 June, which transposes Directive 93/42/EEC. These FAQs aim to clarify key concepts and ensure compliance to maintain safety and efficacy. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

2. Key Definitions

Medical Device

A medical device is defined as any instrument, apparatus, appliance, software, material, or other article intended for human use in diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or handicap; investigation, replacement, or modification of anatomy or physiological processes; or conception control. It does not achieve its primary action by pharmacological, immunological, or metabolic means. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Active Medical Device

An active medical device relies on electrical energy or other power sources (not human body or gravity) for operation, converting such energy. Standalone software is considered active. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Devices for Clinical Investigation

These are devices used by qualified medical practitioners in clinical investigations under Annex XVI, nº 13 of Law-Decree nº 145/2009, in appropriate clinical environments. They must be labeled 'solely for clinical research' and used only under authorized supervision. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Custom-Made Medical Device

A custom-made device is manufactured according to a qualified medical practitioner's written prescription with specific design characteristics for sole use by a particular patient, excluding mass-produced adapted devices. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Medical Device Systems and Sets

These are collections of devices packaged and marketed together under one trade name for specific medical procedures. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

3. Boundaries and Responsibilities

Boundary with Other Products

The boundaries between medical devices and other products are defined in separate guidelines. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Distributor's Role

Distributors are not responsible for placing devices on the market; this falls to the manufacturer. Distributors handle distribution activities. Under other laws, the entity placing products on the national market may bear liability. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Manufacturer Definition

The manufacturer is the natural or legal person responsible for design, manufacture, packaging, and labeling before placing the device on the market under their name, even if operations are outsourced. Only the manufacturer can request conformity evaluation and place devices on the market. They must train and select distributors to ensure quality, safety, and performance. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Authorized Representative

Non-EEA manufacturers must appoint an Authorized Representative established in the Community, who assumes liability to authorities. One representative per device type is required. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

4. Classification and Risk

Medical devices are classified into four risk classes under Directive 93/42/EEC: Class I (low risk), Class IIa and IIb (medium risk), and Class III (high risk). Classification is based on duration of contact, degree of invasion, affected anatomy, and technical risks. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

5. CE Marking and Conformity

Meaning of CE Marking

The CE marking is a prerequisite for market placement and free circulation, guaranteeing conformity to essential requirements. It must be affixed legibly, visibly, and indelibly by the manufacturer on devices, except custom-made or for clinical research. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Characteristics of CE-Marked Devices

CE-marked devices must suit their intended purpose with specified technical specifications, materials, and processes. They must be safe with acceptable risks versus benefits and maintain characteristics without endangering health over their lifespan. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Code Number

A four-digit code indicates involvement of a Notified Body for certain devices (sterile or measuring Class I, IIa, IIb, III, and active implantable). Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Notified Body

A Notified Body is appointed by National Authorities and recognized by the European Commission. It conducts conformity evaluations, authorizes CE marking, issues/renews certificates, ensures quality system compliance, and cooperates with authorities. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Proving Authenticity

Authenticity is proven by the EC Declaration of Conformity plus Competent Authority confirmation for Class I or custom-made devices, and plus the EC Certificate for higher classes. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Recognizing EC Certificate

An EC Certificate includes references to the Directive, procedure/annex, device description, manufacturer/representative details, issue and validity dates, and Notified Body information. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Obtaining CE Marking

The process varies by class under Law-Decree nº 145/2009: Annex VIII for custom-made; Annex VII + EC Declaration for Class I; combinations of annexes for sterile/measuring Class I and higher classes. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

6. Authority and Surveillance

Market Control

The Portuguese Competent Authority (INFARMED) ensures implementation of the Directive, compliance, and safety for patients, users, and third parties. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

INFARMED Competence

INFARMED has competence over all types of medical devices, including active, custom-made, implantable, in vitro, and those for clinical investigation, as well as market surveillance. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Authority Functions

Functions include adopting rules, participating in EU bodies, settling disputes, assessing clinical research, evaluating/recording Class I/custom-made notices, conducting market surveillance, and contributing to the EU database. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq

Checking Compliance

Compliance is checked by the manufacturer for Class I/custom-made/systems (Declaration + notification) and by a Notified Body for higher classes/sterile/measuring (Certificate). Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/medical-devices-md-faq