1. What is the definition of an in vitro diagnostic medical device (IVD)?
An IVD means any medical device, including reagents, calibrators, control materials, kits, instruments, apparatus, equipment, software or systems, intended by the manufacturer for in vitro examination of specimens derived from the human body for providing information. The definition is governed by Regulation (EU) 2017/746 (IVDR).
Specimen receptacles are also deemed to be IVDs.
2. Who controls the medical devices placed on the market?
INFARMED – National Authority of Medicines and Health Products, I.P. - is the Portuguese competent authority for in vitro medical devices covered by Regulation (EU) 2017/746.
INFARMED, I.P. is responsible for monitoring and enforcing compliance with the IVDR and the applicable national legislation.
Its responsibilities include market surveillance, vigilance, registration obligations, the supervision of economic operators and the protection of public health and safety.
3. What are the Competent Authority's functions?
Competent Authorities oversee market surveillance, vigilance, economic operators, performance studies, EUDAMED related activities, cooperation with the European Commission and coordination with other Member-States.
4. What does the CE marking on medical devices mean?
The presence of the CE marking in is a prerequisite for medical devices to be placed on the market and be allowed to circulate freely. It is a guarantee that the products conform to the essential requirements to which they are subject.
The marking has a particular graphic design and shall be affixed by the manufacturer in a legible, visible and indelible form on all medical devices.
Where required, the identification number of the Notified Body accompanies the CE mark.
5. Can the distributor affix the CE marking?
No. Only the manufacturer may affix the CE marking after demonstrating conformity with the IVDR. An authorised representative may act on the manufacturer's behalf where applicable.
6. What are the duties of the Portuguese distributor of IVDs bearing the CE marking?
Distributors make devices available on the market and must comply with the obligations laid down in Article 14 of the IVDR.
Distributors must verify CE marking, UDI information where applicable, instructions and labelling, storage and transport conditions, traceability requirements and cooperation with corrective actions and authorities.
7. What is the definition of a manufacturer?
According to Article 2(23) of Regulation (EU) 2017/746, a manufacturer is the natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or refurbished, and markets that device under its name or trademark.
8. What are the requirements for labelling and other information to be provided by the manufacturer of IVDs intended for the portuguese market?
Labelling and instructions for use must meet Annex I of the IVDR, include required identification and safety information, and be provided in Portuguese for the portuguese market.
9. What must an IVD manufacturer established in Portugal do to obtain the CE marking for his products?
Manufacturers must implement a quality management system, complete the applicable conformity assessment procedure, generate performance evidence and obtain Notified Body certification whenever required under the device classification.
The manufacturer's obligations are laid down in Article 10 of the MDR.
10. What must an IVD manufacturer established in Portugal do to notify his products?
Manufacturers must comply with current registration and economic operator obligations under the IVDR and the procedures required by Infarmed and EUDAMED implementation.
11. Which entities are involved in the evaluation of IVD conformity?
The evaluation of conformity may involve, besides the manufacturer, a Notified Body (and competent authorities/EMA, EURLs and expert panels) depending on the device class (A, B, C or D) and applicable conformity assessment route.
12. What is the Notified Body?
A Notified Body is an organisation designated under the IVDR to assess conformity of devices falling within its scope of designation and to issue the relevant certificates.
The Notified Body as an evaluation body appointed by the national Authority and recognized by the European Commission, is assigned a four-digit identity code. This code accompanies the CE marking on the products evaluated by that body.
The Notified Body's functions are as follows:
- conduct the conformity evaluation procedures;
- authorise the affixing of the CE marking;
- issue certificates of conformity;
- renew, or not, certificates of conformity;
- ensure that the manufacturer complies fully with his duties under the approved quality system;
- cooperate with National Authorities;
- cooperate with other Notified Bodies in EU Member-States.
13. Which procedures should reagent or product importers follow to clear their products through customs?
Importers must ensure compliance with IVDR requirements and any customs, market-access and Infarmed procedures applicable at the time of importation.
