What is the definition of a in vitro diagnostic medical device (IVDD)?
Under Decree-Law no. 189/2000 of 12 th August, transposing the Directive 98/79/CE, an IVDD is: 
  • any in vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used, in vitro , for the examination of samples derived from the human body with a view to provide information on the physiological or pathological states and congenital anomalies, to determine the safety and compatibility of potential recipients or monitor therapeutic measures; 
  • container(s) specifically designed by the manufacturer to contain or preserve samples derived from the human body intended for in vitro diagnosis;
Who controls the medical devices placed on the market?
The Portuguese Competent Authority acts on behalf of the government to ensure that Community Directives are implemented in the country. 
In this context, INFARMED, the Portuguese Authority for medical devices, must ensure that they comply with the legal requirements and do not put at risk the health and safety of patients, users and third parties, as laid down in Directive 98/79/EC. National Competent Authority for IVDD: INFARMED - National Authority of Medicines and Health Products, I.P..
What are the Competent Authority's functions?
The Competent Authority's functions in the field of medical devices are as follows: 
  • Adopt and publish the rule and regulations required to implement Directives; 
  • Take part in European Union working parties and standing committees; 
  • Settle disputes between Manufacturers and Notified Bodies; 
  • Assess applications for clinical research medical devices; 
  • Evaluate notices relating to and keep records of a in vitro diagnostic medical device produced in Portugal; 
  • knowledge of the market and its surveillance, in the after-sales stage 
  • Take part in the setting up of a European medical devices database; 
  • Surveillance of medical devices. 
What are the Competent Authority's functions?
The Competent Authority's functions in the field of medical devices are as follows: 
  • Adopt and publish the rule and regulations required to implement Directives; 
  • Take part in European Union working parties and standing committees; 
  • Settle disputes between Manufacturers and Notified Bodies; 
  • Assess applications for clinical research medical devices; 
  • Evaluate notices relating to and keep records of a in vitro diagnostic medical device produced in Portugal; 
  • knowledge of the market and its surveillance, in the after-sales stage 
  • Take part in the setting up of a European medical devices database; 
  • Surveillance of medical devices.
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, except those that are custom-made or intended for clinical research. 
Can the distributor affix the CE marking? 
No, obligations under the applicable directive are the sole responsibility of the manufacturer (or his authorised representative, if the manufacturer is not established in the Community). Is the manufacturer or its authorised representative, who ensures and declares that the products meet or requirements of the Directive which apply to them.
What are the duties of the Portuguese distributor of IVDDs bearing the CE marking? 
  • The distributor must guarantee that the device's labelling and instructions are written in Portuguese and meet the essential requirements set out in paragraph 8 of Annex I of Decree-Law 189/2000
  • comply with Article 12 of Decree-Law 189/2000 by registering online the IVDD to be sold, in ¿Registration of DM and IVDD¿.
  • comply with the Decree-Law 145/2009 as regards the provisions relating to the activities referred to in point 1 of Article 36º.
What is the definition of a ¿manufacturer¿? 
A ¿Manufacturer¿ is the natural or legal person responsible for the design, manufacture, packaging and labelling of a device, before it is placed on the market under his own name, regardless of whether these operations are carried out by that person or by a third party on his behalf. 
Thus the only person responsible for placing the devices on the market is the manufacturer. Only the manufacturer may request an evaluation of the devices' conformity and place them on the market under his own name. 
It is up to the manufacturer of the medical devices to train and select the distributors who are able to guarantee the device's quality, safety and functional performance up to the moment of its use. 
How should a manufacturer not established in Portugal notify INFARMED that it has placed IVDDs bearing the CE marking on the market? 
Only the IVDD belonging to Annex II or intended to be used for self-diagnosis should be notified:
  • indicating which devices he intends to place on the Portuguese market; 
  • supplying the information laid down in article 10 of Decree-Law no. 189/2000, which should be submitted using the appropriate form " Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive: article 10 ¿, and completing all items applying to the device. The manufacturer should preferably send a copy of the form submitted to the Competent Authority in the country where he is established; 
  • supplying the certificates issued, modified, completed, suspended, withdrawn or refused by the Notified Body 
  • supplying the instructions leaflet (IL) and the planned labels, necessarily written in Portuguese pursuant to Article 5 of Decree-Law no. 189/2000, EC declaration of conformity and EC certificate of conformity.
What are the requirements for labelling and other information to be provided by the manufacturer of IVDDs intended for the Portuguese market? 
The devices shall bear labels and be accompanied by instructions for use written in Portuguese in accordance with Article 5 of Decree-Law no. 189/2000, except for information provided by means of standard symbols. 
The manufacturer is responsible for the translation of the information contained on labelling and the instructions leaflet (IL) for the Portuguese language, so the distributor can only perform this translation after written authorization of the manufacturer, and shall comply fully with the information originally supplied by the manufacturer.
The labelling and IL shall also comply with the provisions of point 8, Annex I of the same Decree-Law.
What must an IVDD manufacturer established in Portugal do to obtain the CE marking for his products? 
See ¿Conformity assessment of IVDD according to Decree-Law no. 189/2000¿
What must an IVDD manufacturer established in Portugal do to notify his products? 
See "IVDD registration by the national manufacturers¿
Which entities are involved in the evaluation of IVDD conformity? 
The conformity of IVDDs that do not constitute a risk when used by duly qualified professionals may, generally speaking, be evaluated on the basis of internal quality control procedures carried out under the sole responsibility of the manufacturer (Annex III of Decree-Law no. 189/2000). 
IVDDs listed in Annex II and IVDDs for self-diagnosis, since they belong to a group of devices whose proper operation is essential to clinical practice and to Public Health safety, require the participation of a Notified Body and the application of stricter evaluation procedures that guarantee the highest degree of safety and reliability. 
What is the Notified Body? 
The Notified Body is an evaluation body appointed by the national Authority and recognized by the European Commission which assigns it 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.
Which procedures should ¿reagent or product¿ importers follow to clear their products through customs?
  1. Any products that may be deemed an IVDD (under the legal definition), in particular a reagent to be used in human samples, may require an Infarmed declaration to clear customs. In such circumstances the importer should ask for a declaration from Infarmed's President by applying to INFARMED's Health Products Directorate (DPS).  
  2. Along with the above declaration, all the documentation requested of the manufacturer should be provided to show that: 
  • statement of the research center that will use the reagent
  • invoice receipt related to the reagent
  • labelling and instruction leaflet