Medical device market and regulatory framework in the European Union

1 Overview

In this article, we will present the functioning of the medical device market and regulatory requirements for them in the European Union (EU)(1). We will focus on medical devices, with the understanding that the same principle in the EU market also works for the In vitro diagnostic medical devices (IVDs) with some exceptions that differ for example in classification. The EU has a competitive and innovative medical devices sector, characterized by the active role of small and medium-sized enterprises. There are over 500 000 types of medical devices and IVDs on the EU market.

2 Current legislation and new Regulations

Medical devices are under current legalization divided into Directives for “general” medical devices under MDD(2), active implantable medical devices under AIMDD(3) and in vitro diagnostic medical devices under IVDMD(4).
After PIP (Poly Implant Protheses) scandal in 2010, European Commission started working on a new regulatory framework to ensure a high level of health and safety protection for EU citizens using medical devices and IVDs. European Commission wanted to ensure the free and fair trade of the medical devices and IVDs throughout the EU and to adapt EU legislation to the significant technological and scientific progress occurring in this sector over the last 20 years (3D printing, nanotechnologies, artificial intelligence, software, etc.). The results were two new Regulations: MDR(5) and IVDR(6) in 2017, which are replacing the three existing directives in the coming years (until 2022). Due to COVID-19 situation in 2020 date of application for MDR was postponed(7). In addition, it was made Corrigenda to the Regulations in May and December 2019. The new legislation will be applicable within the EU on 26 May 2021 for MDR and 26 May 2022 for IVD. To avoid market disruption several transitional provisions are in place until 2025. Main changes comparable to directives in regulations are:
– the updated rules include an implant card and information for patients who have an implanted device,
– a Single Registration Number (SRN) uniquely identifies economics operator in the European Medical Devices Database (EUDAMED),
– a Unique Device Identification (UDI) on the label of the device or its packaging will allow each product to be found in the EUDAMED,
– under MDR will be regulated products without an intended medical purpose (Annex XVI MDR) and
– There is a larger emphasis on monitoring the device throughout its lifetime – vigilance and post-market monitoring.

3 What are medical devices and how are they classified?

Medical devices include all products that are used for the diagnosis, prevention, monitoring, treatment, and alleviation of disease, handicap, invalidity, anatomic functions or physiological processes, birth control, and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means. This means that MD are everything from simple bandages to electromagnetic and mechanical devices for hospital use, surgical instruments and diagnostic tests.
According to the European framework, there are four classes of medical devices(8):
– Class I,
– Class IIa,
– Class IIb and
– Class III.

The medical devices of Class III hold the highest risk. Today, due to the stricter rules of the new regulation system (MDR), the class of many medical devices will be changed. Classification of IVDs as mentioned above is different and will change with IVDR.
It is important to know that for all classes of MD is required to have an EC Declaration of conformity. EC Declaration of conformity is a manufacturer’s obligation. For classes Is (sterile), Im (measuring function), IIa, IIb, and III it is required that the conformity assessment is performed from a Notified Body. Notified body issue to manufacturer EC Certificate of conformity.
The best way to check the designation of the Notified Bodies and review if the Notified Body fulfils the relevant requirements of legislation, under directive or regulation, is NANDO database(9). Every Notified Body has an identification number (four-digit number), which is usually visible on MD next to CE mark.

4 Unique Device Identification (UDI)

In the changes above comparable to directives is mentioned the Unique Device Identification. Under MDR, it is new that in the near future, every medical device will have a specific Basic UDI-DI. This is important for distributors and importers because they will have to co-operate with the manufacturers or with the authorised representatives to achieve an appropriate level of traceability of medical devices.
With UDI system, economic operators will be able to identify:
– to whom they have directly supplied a device,
– who has directly supplied them with a device and
– to which health institution or healthcare professional they have directly supplied a device.
In practice, this means that the economic operators should have the system, which will guarantee the identification and traceability of medical devices, except for the custom-made medical devices and investigational medical devices.

5 CE mark

The CE mark must be affixed by the manufacturer or by his authorized representative. CE mark(10) is the main indicator of a product’s compliance with EU legislation and allows the free movement of products in the European market. When a manufacturer affixes his CE marking, he declares his responsibility that the product complies with all legal requirements.
This means that every medical device, before manufacturer put it to the market, has to have EC Declaration of conformity, EC Certificate of conformity, technical documentation, risk assessment, instruction for use, etc.
Obtaining the CE mark ensures suitable sale of the device throughout the European Economic Area (EEA) – 27 countries EU Member States and EFTA countries Iceland, Norway, Liechtenstein and Turkey. This also applies to medical devices manufactured in third countries and intended for sale in the EEA and Turkey.

6 Import of medical devices from the third country to the EU market

For a medical device to be imported from third country and be made available on the EU market, each manufacturer from third country is obligated to have an authorised representative (legal person established within the Union, who has a mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf) somewhere in the EU.
Importer (legal person established within the Union), places a medical device from the third country on the EU market.
It is important to notice that under new MDR economic operators such as: – manufacturer (MR), – an authorized representative (AR), – system and procedure pack producer (PR) and – the importer (IM) will be obligated to register their activity in EUDAMED Actor module. Nevertheless, this obligation does not apply to distributors. For the distributor Member States may maintain or introduce national provisions on registration of distributors of devices, which have been made available on their territory. There will be six interconnected modules in EUDAMED(11). EUDAMED is an IT system which is developed by the European Commission with purpose to implement MDR and IVDR. In the future it will improve transparency and coordination of information regarding medical devices available on the EU market. The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and it will be interoperable.

6.1 Brexit impact

Regarding medical devices and the EU market it is important to take into consideration the impact of Brexit.
After the United Kingdom (UK) withdrew from the European Union on 1 February 2020 they will, at the end of the transitional period, on 1 January 2021 to be precise, become a third country. In transitional time, there is a need for economic operators to be prepared and ready for new changes(12) such as customs formalities required by EU law, which can lead to longer delivery times.

7 Export of medical devices from the EU market to third countries

When the economic operators want to export medical devices, that have upon conformity assessment procedure obtained the CE mark in accordance with the regulatory requirements of the European Union, they should first verify to which regulatory requirements medical devices should comply in third countries.
For the purpose of export and upon request by a manufacturer or an authorised representative, the Competent authority in Member State in which the manufacturer or the authorised representative has its registered place of business, issues a Certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question is bearing the CE marking under EU requirements.

8 Conclusion

Due to new regulation framework in EU for medical devices and IVDs, in near future, there will be a need to make all adaptions to new requirements. This will require additional efforts from all participants operating in this important health sector. All work will ensure safe and effective medical devices and IVDs for the EU citizens.

Prepared by Marcia Elena Podborsek

December 2020

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