What is a medical device?Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: 

• Diagnosis, prevention, monitoring, treatment or alleviation of disease,  
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• Investigation, replacement or modification of the anatomy or of a physiological process,
• Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device.

Any device intended for use by a duly qualified medical practitioner, when conducting investigations, mentioned in nº 13 of Annex XVI of the Law-Decree nº 145/2009, of the 17th of June, in an adequate human clinical environment.
For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner.
The devices must be duly labelled "solely for clinical research" and may only be used in the context of the clinical research for which they were produced and under the supervision of the staff authorised to carry out the research.

Custom-made medical devices are specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
Custom-made medical devices do not include devices manufactured by a continuous or batch production method that have not been adapted to meet the specific needs of the doctor or any other professional user.

Systems and sets for particular medical procedures consist of various medical devices that are packed and dispensed jointly as a single unit, and are placed on the market under a single trade name.

Here.

No. According to Law-Decree nº 145/2009, of the 17th of June, the distributor, as the name implies, is the entity responsible for distributing the medical devices. Under the law the only entity responsible for placing them on the market is the manufacturer.  However, according to Law-Decree nº 312/2002, of the 20th of December, and Law-Decree nº 264/2003, of the 24th of October, the responsible for the market placing is the person who places the product in our national market, and in that case it can be a distributor as described above. 

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 himself 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.

When a medical device manufacturer has his head office outside the European Economic Area (EEA), he must be represented by an authorised representative established in the Community. The representative assumes the manufacturer's liability before the authorities and other official bodies in the Community. The manufacturer may only be represented by a single authorised representative for each type of device.

Medical devices are divided into four risk classes:

• Class I medical devices - low risk  
• Class IIa medical devices - medium risk  
• Class IIb medical devices - medium risk  
• Class III medical devices - high risk

The risk class is calculated taking into account the following factors: 

1. Length of time in contact with the human body (Transient, short-term and long-term)  
2. Degree of invasion of human body (Invasive, non-invasive) 
3. Part of anatomy affected by its use (Brain, heart, lower limbs, etc. ) 
4. Potential risks stemming from technical design or manufacture

Here.

The CE marking 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 mark 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.

The device shall be suited to its purpose. This dictates the device's technical specifications, the materials to be used and the manufacturing process. If the device's purpose is not clear this should be specified on the labelling which should include the information needed to ensure it is used for the purpose for which it was intended.
Medical devices must be safe. This supposes that a device should not represent a health risk to the patient, users or third parties, and any risks that may be associated with its use must be acceptable when compared with the benefits it brings the patient.
The device shall have the characteristics and performance indicated by the manufacturer. Therefore, its characteristics and performance must not change over the device's life to the point where it endangers the patient's safety. 

Sterile or measurement class I devices and class IIa, IIb and III devices, and active implantable devices require the intervention of a third party, the Notified Body, to guarantee that they conform to the essential requirements to which they are subject.
In such cases the device bears not only the CE marking but also a four-digit code which identifies the Notified Body chosen by the manufacturer to evaluate it.

The Notified Body is an evaluation body appointed by the national Authority and recognised 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 conformity certificates:
• renew, or not, certificates of conformity;
• ensure that the manufacturer complies fully with his duties under the approved quality system;
• cooperate with the National Authorities;
• cooperate with other Notified Bodies in EU Member-States.

The Portuguese Competent Authority acts on behalf of the government to ensure that Community Directives are implemented in the country.

In this context, INFARMED, I.P., 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 the applicable Directives.  
Areas of competence for INFARMED, I.P. regarding medical devices:

• Medical devices
• Active medical devices
• Systems and Procedure packs
• Custom-made medical devices
• Implantable medical devices
• Implantable active medical devices
• Implantable active custom-made medical devices
• In vitro diagnostic medical devices
• Devices intended for clinical investigation
• Surveillance of medical devices

The Authority's functions in the field of medical devices are as follows:

• Adopt and publish the rules 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 class I medical devices and custom-made devices manufactured in Portugal or other countries;
• Market Surveillance - Monitor the after-sales stage of the medical devices market;
• Take part in the setting up of a European medical devices database;
• Surveillance of medical devices.

• In the case of class I devices, custom-made medical devices and Systems and Procedure packs, the conformity assessment procedure is the sole responsibility of the manufacturer, who is required to:
  • Draw-up a Declaration of Conformity;
  • Notify the Competent Authority;
• In the case of class IIa, IIb and III devices and all sterile or measuring devices placed on the market, the notified body chosen by the manufacturer must play a part and may issue a Certificate of Conformity.

• An EC Declaration of Conformity drawn up by the manufacturer and a document, issued by the Competent Authority, confirming the manufacturer¿s notification regarding the market placement of class I medical devices. 
• An EC Declaration of Conformity drawn up by the manufacturer and a document, issued by the Competent Authority, confirming the manufacturer¿s notification regarding the market placement of the custom-made medical devices.  The EC Declaration of Conformity should be made available to the patient.
• An EC Declaration of Conformity drawn up by the manufacturer and an EC Certificate of Conformity issued by the notified body responsible for evaluating the conformity of class IIa, IIb and III devices, of sterile or with measuring function class I medical devices, and implantable active medical devices.

A certificate must include:

• A reference to the applicable Directive
• The procedure followed and a reference to the respective annex(es)  of the Directive  
• A description of the devices concerned
• Name and address of the manufacturer or authorised representative established in the European Union
• Issue date of Certificate
• Validity period
• Name and identity number of the Notified Body responsible for issuing the certificate

For medical devices, to which DIR 93/42/EEC applies, transposed to national law by Law-Decree nº 145/2009, of the 17th of June:
Depending on the classification the Manufacturer assigns to the medical device, to be placed on the market, the procedures to be followed in order to affix the CE marking are the following:

Custom-made medical devices

The Manufacturer shall comply with the provisions of annex VIII of Law-Decree nº 145/2009, of the 17th of June.

Class I devices

The Manufacturer shall follow the procedures set out in annex VII of Law-Decree nº 145/2009, of the 17th of June, and draw up the EC Declaration of Conformity.

Class I sterile and with measuring function medical devices

The Manufacturer shall draw up a EC Declaration of Conformity in accordance with annex VII of of Law-Decree nº 145/2009, of the 17th of June , and choose one of the following evaluation procedures: 

• annex IV,   or
• annex V, or 
• annex VI.
• annex II (excluding part II).

Class IIa medical devices

The Manufacturer shall choose one of the following evaluation procedures referred to in Law-Decree nº 145/2009, of the 17th of June: 

• annex II (excluding part II), or  
• annex VII in combination with one of the following annexes: IV, V or VI.

Class IIb medical devices

The Manufacturer shall choose one of the following evaluation procedures referred to in Law-Decree nº 145/2009, of the 17th of June: 

• annex II (excluding part II), or  
• annex III in combination with one of the following annexes: IV, V or VI.

Class III medical devices

The Manufacturer shall choose one of the following evaluation procedures referred to in Law-Decree nº 145/2009, of the 17th of June: 

• annex II (including part II), or  
• annex III in combination with one of the following annexes: IV or V.

Implantable active medical devices, to which Directive 90/385/EEC applies, also transposed to national law by Law-Decree nº 145/2009, of the 17th of June, the Manufacturer shall choose one of the following evaluation procedures:

• annex XI, or  
• annex XII in combination with one of the following annexes: XIII or XIV.