Regulation of In Vitro Diagnostic Medical Devices in Portugal

1. Overview

INFARMED, I.P., the Portuguese National Authority for Medicines and Health Products, oversees the regulation of in vitro diagnostic medical devices (IVDDs) to ensure their safety, performance, and compliance with European standards. The framework is established by Decree-Law no. 189/2000 of 12 August, which transposes Directive 98/79/EC into national law. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

2. Definition of IVDDs

An IVDD is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system—used alone or in combination—intended by the manufacturer for in vitro examination of human-derived samples. It provides information on physiological or pathological states, congenital anomalies, safety and compatibility for recipients, or therapeutic monitoring. Sample containers designed for preservation are also considered IVDDs. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

3. Applicable Legislation

The primary legislation is Decree-Law no. 189/2000, incorporating Directive 98/79/EC. Additional regulations include Decree-Law no. 145/2009 for activities under Article 36. References to annexes outline essential requirements, conformity assessments, and specific provisions for self-diagnosis and high-risk devices. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

4. Responsibilities of Economic Operators

Manufacturer

The manufacturer is responsible for design, manufacture, packaging, and labelling before market placement. They request conformity evaluations, declare conformity, and ensure quality, safety, and performance through distributor training. Non-Portuguese manufacturers notify INFARMED for Annex II or self-diagnosis IVDDs using specific forms, providing certificates, Portuguese instructions, and declarations. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

Distributor

Portuguese distributors ensure Portuguese labelling and instructions comply with essential requirements. They register IVDDs online per Article 12 and adhere to Decree-Law no. 145/2009. Translations require manufacturer authorization. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

Importer

For customs clearance of potential IVDDs like reagents, importers obtain a declaration from INFARMED's Health Products Directorate, providing user statements, labelling, and manufacturer documentation. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

5. CE Marking

The CE marking guarantees conformity with essential requirements and is mandatory for market placement. It must be affixed visibly and indelibly by the manufacturer. A four-digit code indicates Notified Body involvement for certain devices. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

6. Conformity Assessment Procedures

Low-risk IVDDs undergo internal quality control under manufacturer responsibility (Annex III). High-risk (Annex II) and self-diagnosis devices require Notified Body involvement. Manufacturers in Portugal follow steps for CE marking and notify INFARMED for registration. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

7. Notified Body

Notified Bodies, appointed by national authorities and recognized by the European Commission, conduct evaluations, authorize CE marking, issue certificates, ensure quality compliance, and cooperate with authorities. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

8. Market Surveillance and Authority Functions

INFARMED ensures Directive implementation, compliance, and safety. Functions include rulemaking, EU participation, dispute resolution, clinical research assessment, record-keeping, market surveillance, and database contributions. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation

9. Important Notes

This framework emphasizes safety for patients and users, with strict requirements for high-risk IVDDs. For detailed procedures, refer to the annexes and specific guidelines. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/in-vitro-diagnostic-medical-devices-ivdds-and-applicable-legislation