Competent Authorities
Medical devices and in-vitro diagnostics may only be put into circulation or operation if they fulfil the fundamental requirements specified in the EU regulations.

The competent authorities of the EU member states are responsible for ensuring the enforcement of EU regulations within their countries and take part in the notification and approval procedure for medical devices and in-vitro diagnostics ⁰.

INFARMED
The National Competent Authority acts on behalf of its government ensuring that community directives and regulations are implemented in your country.

In this context, INFARMED is the Portuguese Competent Authority for Medical Devices. INFARMED should ensure that Medical Devices comply with legal requirements and do not compromise the health and safety of patients, users and third parties, as set out in the European Directives and Regulations ⁰.

The functions of the Competent Authority of Medical Devices are as follows ⁰:
− Adoption and publication of national laws and regulations necessary for the implementation of directives and regulations;
− Participation in EU working groups and standing committees;
− Resolution of conflicts between Manufacturers and Notified Bodies;
− Evaluation of medical device requirements for clinical research;
− Evaluation of notifications and maintenance of records of class I and custom-made medical devices manufactured in their territory;
− Market knowledge and its supervision;
− Cooperation in the creation of a European database of medical devices;
− Surveillance of medical devices.

Innovators are encouraged to engage with their competent authorities early in the process to clarify questions, responsibilities and requirements for placing their products on the Portuguese market, as well as in respect to conducting clinical investigations or performance evaluations for their products in Portugal.

Notified Bodies
The Notified Body (NB) is an evaluation body appointed by the Nominating Authority and recognised by the European Commission, which assigns it a four-digit identification code. This code appears associated with the CE marking on products that have been evaluated by it ⁰.

Notified Bodies are nationally accredited bodies that examine the conformity of manufacturers and of their products with regards to the EU regulations for medical devices and in-vitro diagnostics. Manufacturers can refer to any Notified Body of their choice in the European Union, as long as the respective Notified Body has been officially designated to perform conformity assessments for the specific product category and assessment procedure concerned (e.g. medical device manufacturers should consider only Notified Bodies that were certified according to the new EU Medical Device Regulation).

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult the NANDO (New Approach Notified and Designated Organisations) database on this link.

The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the product and the conformity assessment route chosen by the manufacturer, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device. The technical documentation is assessed against the General Safety and Performance Requirements (GSPRs) within the EU Regulations and considers the relevant guidance set out by the EU ⁰.

Typical activities of a Notified Body include ⁰, ⁰:

• full quality assurance: the Notified Body will carry out an assessment of the manufacturer’s quality system (e.g. according to ISO 13485), including design; they will sample across the range of products and processes to ensure that the requirements are being met;
• review of technical documentation: the Notified Body will assess the full technical documentation relating to each type of product to ensure that they meet the requirements;
• type examination: the Notified Body will assess the full technical information relating to each type of product and carry out appropriate testing of a representative sample of production to ensure that it meets the requirements;
• verification: the Notified Body will either test every unit or every batch of product to ensure that they are meeting the requirements before the manufacturer can place them onto the market;
• production and product quality assurance: the Notified Body will carry out an assessment of either the manufacturer’s quality system covering production and inspection (production QA) or final inspection (product QA); they will sample across the range of products to ensure that relevant technical files are available as well as ensuring that the relevant processes being undertaken meet the requirements;
• clinical and performance evaluations assessment;
• unannounced audits of manufacturers.

Innovators should examine whether a Notified Body is the right partner for the conformity assessment procedure for their product and market in scope, before signing a contract with them:

• is the Notified Body designated under the new EU regulations (as opposed to the expiring EU directives)?
• will the Notified Body be affected by Brexit (e.g. is it located in the UK and will not be able to issue CE marking certificates if/when the UK leave the EU)?
• is the Notified Body qualified and experienced to assess the product in question?
• does the Notified Body have availability to conduct the assessment within a reasonable timeframe?
• is the pricing quote of the Notified Body in range with other Notified Bodies that were contacted?

Medical Device Coordination Group (MDCG)
The Medical Device Coordination Group (MDCG) is an expert panel established under the new EU regulations (MDR and IVDR) and is composed of members representing the Competent Authorities of the Member States. Each Member State appoints a member with expertise in medical devices and another member with expertise in in-vitro diagnostics. The MDCG provides advice to the European Commission and assists the Commission and the member states to ensure a harmonised implementation of the new regulations on medical devices and in-vitro diagnostics. The MDCG will function at the request of the commission in regards to ^{0, 0}:

• assessment of applicant conformity assessment bodies;
• guidance development to ensure regulation harmonisation, for designating and monitoring Notified Body, for application of general safety and performance requirement, for the conduct of clinical evaluations and investigation, for vigilance activities;
• monitoring of technical progress and assessing the adequacy of general safety and performance requirements of regulation;
• contribution to the development of the device and common specification standards, scientific guidelines and clinical investigation guidelines for implantable devices and Class III devices;
• assistance to member state competent authorities in classification and regulatory status determinations, clinical investigation and market surveillance;
• collaboration with a commission to set up a unique device identification database;
• contribution to harmonised administrative practice.

Innovators need to closely follow guidance published by the MDCG and its subgroups on the practical implementation aspects and interpretation of the new EU regulations, as well as new common specification standards. Guidance documents adopted by the MDCG can be found on this link.

New medical devices and in-vitro diagnostics intended to be marketed in the European Union must comply with requirements set in the EU regulation for medical devices (MDR, 2017/745) and for in-vitro diagnostics (IVDR, 2017/746).

The General Safety and Performance Requirements (GSPR) that need -to be complied with by medical devices or in-vitro diagnostics are defined in Annex I of the MDR or IVDR.

In addition to compliance with GSPR, manufacturers must select an appropriate conformity assessment procedure depends on the risk classification of the product in order to certify their products and production processes.

Key Obligations for Manufacturers of Medical Devices and In-Vitro Diagnostics
The medical device and in-vitro diagnostic regulation (MDR, 2017/745 and IVDR, 2017/746) outline a set of key obligations required for placing products on the EU market. In particular, manufacturers shall ⁰, ⁰:

• have systems for risk management and quality management;
• have a responsible person for regulatory compliance*;
• conduct clinical evaluations (for medical devices) or performance evaluations (for in-vitro diagnostics)
• maintain technical documentation;
• apply a conformity assessment procedure;
• be responsible for their products (e.g. by taking corrective actions and reporting incidents) and must be able to cover financially for harm caused by their products;
• have a contract with an authorised representative inside the EU/EEA (for manufacturers are established outside of the EU/EEA);
• provide an implant card for patients (for selected implantable medical devices);
• draw up a declaration of conformity and apply CE marking to their product.

*Micro enterprises (<10 employees and turnover < 2 million Euro) and small enterprises (<50 employees and turnover < 10 million Euro) are not required to have a person responsible for regulatory compliance within their organisation but shall have such a person permanently and continuously at their disposal ⁰.

Risk-Based Classification of Medical Devices
Classification of medical devices should be taking into account the intended purpose of the devices and their inherent risks (i.e. invasiveness and duration of use) and has to be carried out based on the classification rules in Annex VIII of the MDR (2017/745) ⁰.

The 22 rules for determining the risk classification of your medical devices can be found on this link and below, and distinguish between non-invasive (Rules 1 – 4), invasive (Rules 5 – 8) and active medical devices Active devices (Rules 9 – 12), as well as special cases (“special rules”: Rules 13 – 23).

The following table shows the different risk classes of medical devices ⁰, ⁰:

Conformity Assessment Procedures for Medical Devices
Manufacturers may choose from different appropriate conformity assessment procedures (as described in Annexes IX through XI of the MDR (2017/745)) depending on the risk class associated with their medical device.

Overview of conformity assessment procedures for medical devices, e.g. adapted from ⁰, ⁰

External stakeholders may be involved (depending on the risk class of the medical device) ⁰, ⁰:

• selected class I medical devices may be self-certified (only if they are not supplied sterile, with measuring funding or as re-usable surgical instruments);
• class IIa, IIb and III medical devices require the involvement of a Notified Body, as well as class I medical devices that are sterile, have a measuring funding or are re-usable surgical instruments);
• selected class IIb and III medical devices also require a clinical evaluation consultation procedure by an independent expert panel (for class IIb active devices intended to administer or remove medicines from the body and for class III implantable devices).

The Article 52 of Regulation 2017/745, defines the conformity assessment procedures for each class.

Risk-Based Classification of In-Vitro Diagnostics
Classification of in-vitro diagnostics takes into account the intended purpose of the in-vitro diagnostic and its risk to the individual as well as to the public health and has to be carried out based on the classification rules in Annex VIII of the IVDR (2017/746) ⁰, ⁰.

The seven rules for determining the risk classification of an in-vitro diagnostic can be found on this link. Note that if more than one rule applies, the rule resulting in the highest classification should be followed.
The following table shows the different risk classes of in-vitro diagnostics ⁰, ⁰, ⁰.

Classification of an in-vitro diagnostic is the responsibility of the manufacturer. If the Notified Body disagrees with the manufacturer’s classification, the decision on classification should be referred to the Competent Authority of the country in which the manufacturer (or its authorised representative) is established.

In-Vitro Diagnostic Classification
Manufacturers may choose from different appropriate conformity assessment procedures (as described in Annexes IX through XI of the IVDR (2017/746)), depending on the risk class associated with their in-vitro diagnostic.

Overview of conformity assessment procedures for in-vitro diagnostics, e.g. adapted from ^{0 0}

Some External stakeholders must be involved (depending on the risk class of the in-vitro diagnostic) ⁰:

• class A in-vitro diagnostics may be self-certified (only if they are not supplied sterile);
• class B, C and D in-vitro diagnostics require the involvement of a Notified Body, as well as class A in-vitro diagnostics that are sterile;
• class D in-vitro diagnostics may also require the involvement of an EU reference laboratory to verify the performance claimed by the manufacturer. In addition, certain class D in-vitro diagnostics also require a performance evaluation consultation procedure by an independent expert panel.

Specific consultation procedure and considerations for products that are associated with a medicine
The new EU regulations for medical devices and in-vitro diagnostic medical devices introduced new responsibilities for the EMA and for national competent authorities for medicines (INFARMED in Portugal).

In particular, for selected medical devices and in-vitro diagnostics that are associated with a medicine, a consultation procedure with EMA or a national competent authority may be required (e.g. at the request of a Notified Body) ⁰.

• Medicines that include a medical device (‘combination products’): medicines can be marketed in combination with a medical device, usually to enable the delivery of the medicine. If the intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicine. The regulatory requirements for the medical device differ depending on whether it is a single integrated product (e.g. prefilled syringes) or a co-packaged product (e.g. reusable pen for insulin cartridges). Medical devices that are co-packaged or obtained separately must be CE marked in accordance with the medical device legislation. The marketing authorisation application should include a CE certificate or declaration of conformity for the device from a Notified Body.
• Medical devices with an ancillary medicinal substance: a medical device may contain an ancillary medicinal substance to support the proper functioning of the device (e.g. bone cement containing an antibiotic). These products fall under the medical devices legislation and must be CE marked. If the ancillary substance is derived from human blood or plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines, the Notified Body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance before it can issue a CE certificate. For other substances, the Notified Body can seek the opinion of a national competent authority or EMA.
• Companion diagnostics (‘in-vitro diagnostics’): a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicine, by identifying patients that are suitable for treatment. The Notified Body must seek a scientific opinion from EMA or a national competent authority on the suitability of the companion diagnostic to the medicinal product concerned.
• Medical devices made of substances that are systemically absorbed: some medical devices are made of substances that are absorbed by the human body to achieve their intended purpose. These invasive devices are normally introduced into the body via an orifice or applied to the skin. The Notified Body must seek a scientific opinion from EMA or a national competent authority on the compliance of the substance.
• Borderline products: borderline products are complex healthcare products for which there is uncertainty over which regulatory framework applies. Commonly, borderlines are between medicines, medical devices, cosmetics, biocide products, herbal medicines and food supplements. Applicants who are unclear on the classification of their product should consult a national competent authority and provide information on the product’s composition and constituents, a scientific explanation of the mode of action and its intended purpose.

More information on the requirements and consultation procedures for medical devices that are linked to medicine use can be found on the EMA webpage.

Declaration of conformity
The declaration of conformity is the commitment of manufacturers to comply with the EU regulations for medical devices or in-vitro diagnostics as well as other applicable regulations. The declaration of conformity is required for all classes of medical devices or in-vitro diagnostics and must be signed off by manufacturers ⁰.

The EU declaration of conformity has to contain all of the following information (see Annex IV of the MDR or IVDR) ⁰, ⁰:

• name, trade name or trademark and address of the manufacturer or its authorised representative;
• a statement that the declaration of conformity is issued under the sole responsibility of the manufacturer;
• a statement that the product is in conformity with the medical devices or in-vitro diagnostics regulations and with any other relevant legislation required for the issuing of the declaration of conformity;
• reference to any Common Standards used and in relation to which conformity is declared;
• if applicable, the name and identification number of the Notified Body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
• product description allowing identification and traceability, including basic UDI-DI, product/ trade name, product code, catalogue number, photograph, as well as its intended purpose;
• risk class of the product;
• place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Important considerations when preparing a declaration of conformity
The following important aspects should be considered when preparing a declaration of conformity ⁰:

• Specify responsibilities for declaration of conformity: as there are far-reaching legal and financial consequences of an unauthorised or incorrect conformity assessment, manufacturers should define (e.g. in a process instruction in the QM system) who is responsible for creating the declaration of conformity (e.g. the regulatory compliance officer) and who is responsible for approving it (e.g. the CEO in case of an SME).
• Choose the right moment to create the declaration of conformity: declaration of conformity must happen before affixing the CE mark to the product, but only after completion of the conformity assessment procedure (depending on the product class reference to certificates from the Notified Body must be made in the declaration of conformity).
• Define the product in detail: the declaration of conformity must refer to an identifiable product or product type, reference to a medical device or in-vitro diagnostic class is not permitted.
• Have the declaration of conformity ready: the declaration of conformity must be available as part of the technical documentation for the medical device or in-vitro diagnostic. A manufacturer must be able to submit these documents at any time requested (e.g. by a competent authority or a Notified Body). Many manufacturers even choose to publish the declaration of conformity directly on the company website.
• Do not declare conformity for an indefinite time period: a declaration of conformity that does not refer to a limited validity does not comply with regulatory requirements. Validity can, for instance, be limited to a defined period of time after the first sold product, to a defined point in the future, to a certain number of products or batches produced or to the time when the CE marking certificate by the Notified Body expires.
• Do not reference to entire standards: reference to entire standards in the declaration of conformity results in the obligation to comply with the entire standard even if certain part does not apply to a manufacturer’s situation. Furthermore, the declaration of conformity would require amendment every time the standard changes.

 
CE Marking of Conformity
By affixing the CE (Conformité Européenne) marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and has been assessed to meet high safety, health, and environmental protection requirements. However, a CE marking does not indicate that a product has been approved as safe by the EU or by another authority, also it does not indicate an origin of the product.

The CE mark is applicable throughout the European Economic Area (i.e. EU member states plus Iceland, Liechtenstein and Norway) as well as in Switzerland and Turkey. No medical device or in-vitro diagnostic can be placed on the EEA market without a CE mark, even if the product is manufactured outside of the European Union. However, products that are intended only for clinical investigation or performance evaluation, or that are custom-made, may not require a CE mark ⁰, ⁰.

Affixing of the CE mark
Once the necessary steps have been successfully completed, the CE mark must be affixed to the medical device or in-vitro diagnostic according to Annex V of the MDR or IVDR. The CE mark has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying documents. The CE mark shall consist of the initials ‘CE’ taking the following form ⁰, ⁰, ⁰.

The various components of the CE mark must have the same vertical dimension and may not be smaller than 5 mm (this minimum dimension may be waived for small-scale products). If the CE mark is reduced or enlarged, the proportions given in the graduated drawing above must be respected. If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed on the CE mark ⁰, ⁰, ⁰.