Regulation (EU) 2017/745 establishes different conformity assessment procedures for each class of medical device, depending on the potential risk to the patient's health.

Class I

Class I medical devices can be certified by the manufacturer or by a notified body. The manufacturer must establish a quality management system (QMS) that ensures the conformity of its products with the requirements of the MDR.

• The manufacturer must establish a QMS that complies with the MDR requirements.
• The manufacturer must carry out a conformity assessment of the product, which includes verification of the design, manufacture, testing, and labelling of the product.
• The manufacturer must carry out a conformity assessment of the quality management system.
• The manufacturer must issue a declaration of conformity.

If the class I product has a measuring function or sterile conditions, the QMS must be audited by a notified body.

Class IIa

Class IIa medical devices can be certified by the manufacturer or by a notified body. The manufacturer must establish a QMS and carry out a clinical evaluation of their product.

• The manufacturer must establish a QMS that complies with the MDR requirements, which will be audited by a notified body.
• The manufacturer must carry out a clinical evaluation of the product.
• The manufacturer must carry out a conformity assessment of the quality management system.
• The manufacturer must issue a declaration of conformity.

Class IIb

Class IIb medical devices must be certified by a notified body. The notified body must carry out a full clinical evaluation of their product.

• The manufacturer must submit an application for conformity assessment to the notified body.
• The notified body must carry out a full clinical evaluation of the product.
• The notified body must issue a certificate of conformity.

Class III

Class III medical devices must be certified by a notified body. The notified body must carry out a full clinical evaluation of their product and a design conformity assessment.

• The manufacturer must submit an application for conformity assessment to the notified body.
• The notified body must carry out a full clinical evaluation of the product.
• The notified body must carry out a conformity assessment of the product's design.
• The notified body must issue a certificate of conformity.

According to Regulation (EU) 745/217 on Medical Devices and its Article 2, it is defined as:

1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception,

• products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Classes of MDs

Medical devices are classified into four classes, according to their potential risk to the patient's health:

• Class I: low-risk products, such as bandages, gauzes, thermometers, etc.
• Class IIa: moderate-risk products, such as surgical dressings, syringes and needles for administering medication.
• Class IIb: high-risk products, such as pacemakers, insulin pumps, etc.
• Class III: very high-risk products, such as implants, in vitro diagnostic devices, etc.

Classes of IVDs

IVDs are classified into four classes, according to their potential risk to the patient's health:

• Class A: low-risk IVDs, such as pregnancy tests or blood glucose tests.
• Class B: moderate-risk IVDs, such as blood tests to detect infectious diseases.
• Class C: high-risk IVDs, such as genetic tests or cancer detection tests.
• Class D: very high-risk IVDs, such as prenatal diagnostic tests or blood compatibility tests.

1. Manufacturer: among other responsibilities, they must ensure that the product complies with all relevant EU requirements, carry out the conformity assessment, draw up the technical file, issue the EU Declaration of Conformity, and affix the CE marking to the product.
2. Authorised Representative: if the manufacturer is not established in the EU, they may appoint an authorised representative based in the EU. This representative acts on behalf of the manufacturer for certain tasks, such as ensuring the availability of the technical file and the declaration of conformity or cooperating with the competent national authority and providing the necessary information and documentation to demonstrate a product's conformity in the event of a reasoned request.
3. Importer: broadly speaking, they must verify that products manufactured outside the EU comply with the necessary requirements before being placed on the EU market, ensuring that the manufacturer has carried out the appropriate conformity assessment and that the product bears the CE marking. In addition, among other possible commitments, they may be subject to registration in official databases or to paying taxes for their recycling.
4. Distributor: they must ensure that the products they distribute comply with current EU legislation before marketing them, verifying that the manufacturer and importer have fulfilled their obligations.
5. Notified Body: this is an entity designated by an EU member state, independent and authorised to assess whether a product meets the specific requirements. Its involvement is mandatory for certain higher-risk products.
6. Laboratory: an accredited laboratory is one that has demonstrated to a national accreditation body (e.g. ENAC in Spain) its technical competence, impartiality and quality management according to the international standard ISO IEC 17025. Accreditation ensures that the tests it performs and the results obtained are reliable, officially recognised and serve as a valid basis for product certification and presumption of conformity.

Risk analysis for a medical device is a systematic process to identify, evaluate, and control potential risks associated with the use of the product. This analysis ensures that all identified risks are reduced to acceptable levels, guaranteeing the safety and performance of the product throughout its lifecycle.

Laboratory tests are scientific tests performed to verify that the product complies with specified safety and performance requirements. These tests ensure that the product is safe and effective for its intended use, evaluating aspects such as biocompatibility, functionality, electrical safety, and electromagnetic compatibility. Laboratories may or may not be accredited for the tests they perform. The choice of an accredited laboratory will depend, in Module A (self-certification), on the manufacturer itself and on the certification body (notified body) for the other modules. Accredited laboratories are subject to the requirements imposed by the accrediting entity, which include procedural and management aspects (e.g., annual audits, equipment calibration, staff qualifications and skills, specific documentation, and restriction of the services they offer). Accredited laboratories are not permitted to provide technical advice to their clients; their functions are purely for verification and evaluation.

The clinical evaluation for a medical device is a systematic process of collecting and analysing clinical data to verify the safety and performance of the product. This process includes reviewing clinical studies, scientific literature, and post-market data to ensure that the product meets regulatory requirements and is safe for use in patients.

The technical file of a medical device is the complete set of documentation that demonstrates the product's conformity with regulatory requirements and describes its performance and construction details. It includes information on the design, manufacture, risk assessment, laboratory tests, and clinical evaluation of the product, ensuring that it complies with safety and efficacy regulations.

The user manual for medical devices is a document that provides clear and complete instructions on the safe and effective use of the product. It includes information on installation, operation, maintenance, and warnings about potential risks, ensuring that users understand how to use the device correctly and prevent damage or malfunctions.

The Marking of a medical device is the information provided directly on the device and/or its packaging. It must include essential data such as the product name, the manufacturer, instructions for use, warnings, and the CE marking, ensuring that users have all the necessary information for the safe and proper use of the device.

Regulation 2017/745/EU imposes requirements to ensure the quality of medical devices through the implementation of a quality management system (QMS). The ISO 13485 standard sets out the requirements for a quality management system specific to medical devices. It ensures that organisations can consistently provide products that meet regulatory and customer requirements, focusing on safety and performance throughout the product's entire life cycle.

The UDI EUDAMED Registration is a mandatory unique device identification (UDI) system that allows for the tracking and monitoring of medical devices in the European database EUDAMED. It facilitates transparency, traceability, and surveillance of medical devices, improving patient safety and risk management.

The import/manufacturing licence for medical devices is an official authorisation, granted by government entities, that allows an entity to manufacture or import medical devices within the European Economic Area. This licence aims to verify that the entities (importers or manufacturers) have fulfilled their legal obligations and that the products they market comply with the safety and efficacy requirements established by European regulations.

An Authorised Representative for medical devices is a natural or legal person established in the European Union (EU) who acts on behalf of a manufacturer outside the EU. This representative ensures that the products comply with regulatory requirements and handles communication with competent authorities and notified bodies. All manufacturers located outside the EU must have an Authorised Representative located in the EU to be able to introduce their products into this territory.

Market surveillance and vigilance for medical devices is a continuous system of collecting and analysing data on the performance and safety of products after they have been placed on the market. This process allows for the identification and management of potential risks, ensuring that products continue to meet regulatory requirements and protecting public health.

A harmonised standard for medical devices is a European standard that provides technical specifications and compliance criteria to ensure that medical devices meet the safety and performance requirements established by legislation. Compliance with these standards facilitates the demonstration of conformity with the regulation and simplifies the certification and marketing process in the European market.

The presumption of conformity for medical devices is the recognition that a medical device complies with regulatory requirements by having used applicable harmonised standards to verify its technical requirements. The presumption of conformity facilitates the product's evaluation and certification process, allowing it to be marketed in the European Economic Area with greater confidence and efficiency.

Some products that do not fit the definition of MDs and IVDs are covered by Annex XVI of Regulation (EU) 2017/745. These products, due to their nature and risk during use, do not have a medical purpose, but Regulation (EU) 2017/745 imposes requirements for their marketing.

The products covered by this annex are part of the following categories.

• Contact lenses
• Products intended to modify anatomy
• Facial fillers
• Equipment intended to reduce, remove or destroy adipose tissue (liposuction, lipolysis or lipoplasty)
• Equipment emitting high-intensity electromagnetic radiation for skin rejuvenation, hair removal, tattoo removal or other dermal treatments.
• Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields

These products are subject to general safety and efficacy requirements. However, they are not subject to the specific requirements for medical devices, such as clinical evaluation requirements or market surveillance requirements.

The transition from the Medical Device Directive 93/42/EEC (MDD) to the Medical Device Regulation (EU) 2017/745 (MDR) has followed a specific timeline to ensure adequate adaptation by manufacturers and other stakeholders:

1. Date of entry into force: The MDR (EU) 2017/745 was published in the Official Journal of the European Union on 5 May 2017 and entered into force on 25 May 2017.
2. Transition period: A three-year transition period was established, initially scheduled to end on 26 May 2020. This period allowed manufacturers to adapt their processes and documentation to the new requirements.
3. Extension of the transition period: Due to the COVID-19 pandemic, the European Commission proposed an extension of the transition period, and the new date of full application of the MDR was set for 26 May 2021.
4. Devices with valid MDD certificates: Devices that still had valid certificates issued under the MDD could continue to be marketed until those certificates expired, but no later than 26 May 2024, provided that no significant changes were made to the design and intended purpose of the device.
5. Post-market requirements: During this time, manufacturers must comply with certain MDR requirements, such as post-market surveillance and traceability through the UDI system.

These transition times have been essential to allow for an effective implementation of the new regulatory framework, with the intention that all products on the market comply with the high standards of safety and quality established by the MDR.