A complete guide to making available a medical device in the European Union

The making available of medical devices in the European Union is a process regulated by strict standards, specifically Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

If you want a simple overview of the regulations, this guide outlines the essential steps to making available your medical device in the EU , all while complying with the current regulations.

1. Classification of medical devices

The first step in making available a medical device is to determine its classification. In the EU, medical devices are divided into four classes (I, IIa, IIb, III), according to the level of risk associated with their use.

According to Article 51 of the MDR, "Devices shall be classified into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks." This classification is crucial as it establishes the specific regulatory requirements the device must adhere to.

2. Compliance with regulatory requirements

Once the device is classified, the manufacturer must ensure that it complies with all the essential requirements of the MDR. This includes risk management, clinical evaluation, performance, and safety of the device.

Chapter 1.1 of Annex I stipulates the following: "Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons."

3. Implementation of a quality management system

Manufacturers must implement a quality management system (QMS) in accordance with the ISO 13485, which outlines the specific requirements for medical devices. This QMS must cover all aspects of production, quality assurance and distribution of medical devices.

Article 10(9) of the MDR specifies: "Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device."

4. Clinical evaluation

Clinical evaluation is a crucial step in demonstrating the safety and efficacy of a medical device. Depending on the device’s risk class, a clinical study may be necessary to prove that it meets the regulatory requirements for safety and performance.

"Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III."

5. Obtaining the CE marking

The CE marking is mandatory for the making available of medical devices in the EU. This marking confirms that the device complies with the safety and performance requirements defined by European regulations. For class IIa, IIb, and III devices, an intervention of a notified body is required before bearing the CE marking.

To do this, the manufacturer must submit the device's technical file to the notified body that will carry out the intervention. Once the CE marking is obtained, the device can be made available on the market.

We find this information in Article 20 of the MDR: "Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V." 

Annex IX, Chapter II, Section 5.1 of the MDR specifies: "For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV."

6. Declaration of conformity

After obtaining the CE marking, the manufacturer must draft a declaration of conformity certifying that the device complies with and fulfils all applicable regulatory requirements in the EU.

Article 19 of the MDR stipulates: "The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity."

7. Registration of the device in Eudamed

Before making available on the market the device in the EU, it must be registered in the European database on medical devices (Eudamed). This registration is mandatory and ensures the traceability of devices in the European market.

Article 29 of the MDR stipulates: "Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated"

8. Post-market surveillance

Once the device is placed on the market, it is essential to maintain a surveillance system to continuously assess its safety and performance. This step allows for the rapid detection and management of any issues that may arise after marketing.

Article 83 of the MDR establishes that: "For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9)." 

9. Appointment of an authorised representative (for manufacturers outside the EU)

Manufacturers located outside the European Union must designate a European Authorised Representative (EC-REP). This representative acts as an intermediary between the European regulatory authorities and the manufacturer. Their role is crucial, as they ensure that all regulatory requirements are met and that the necessary documents are available at all times.

• Particular case of the United Kingdom and Switzerland: Since Brexit, and due to specific bilateral agreements, British and Swiss manufacturers must also designate an authorised representative based in the EU, as they no longer benefit from the automatic recognition of their local representatives.

10. Importance of specialised translation

When making available a medical device in the EU, it is essential to ensure that all documentation, including instructions for use, labelling, and technical files, is translated into the official languages of the EU member states where the device will be distributed.

According to Article 10(11) of the MDR: "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient." 

Relying on a specialised translation company is crucial to ensure that the documents are accurate and in compliance with all these requirements. An erroneous or inaccurate translation can lead to misunderstandings, regulatory non-compliance, and even legal penalties. Translation agencies working with translators specialised in areas such as medical, pharmaceutical, dental or medical device translation not only possess the linguistic skills but also the technical understanding necessary to correctly translate complex and sensitive documents.

Conclusion

The making available on the market of a medical device in the European Union is a complex process that requires particular attention at each stage to ensure compliance with the MDR. By following the steps described in this article and complying with all regulatory requirements, manufacturers can ensure patient safety and effective marketing. Working with experts in specialised regulations and medical device translation processes can maximise your chances of success in the European market.