New regulations for entrepreneurs in the medical market

From May 26, 2021, the new provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, which was amended by Regulation (EU) 2020/561, due to the change of the date of entry into force of the regulation, apply. They impose new obligations on entrepreneurs as part of the procedures for releasing medical products to the market and create new control systems by creating databases. Everything about the regulation introducing new regulations for entrepreneurs of the medical market in the article below.

Regulation introducing new regulations for entrepreneurs in the medical market

As part of the many years of work of the European Union, the EU Regulation 2017/745 was created, which was created in order to improve the functioning of the internal market in the field of medical devices, and above all, to protect the health of patients. It imposes on the Member States the safety and control procedures that will have to be implemented and the results will be communicated to the relevant authorities (preamble to EU Regulation 2017/745).

This regulation is not intended to harmonize the rules, on the contrary, the new rules are intended to strengthen the main elements of the current regulatory approach, such as conformity assessment procedures, clinical trials and clinical evaluations.

As part of the regulation, new databases are created to improve the system of control, quality and procedures related to the production of medical devices.

UDI and EUDAMED

Pursuant to the regulation, a special system of unique product identification codes has been created. The newly created database aims to facilitate the identification of medical devices in the European Union (Article 27 of the EU Regulation 2017/745). Before a product is released on the market, the product must obtain a special BASIC UDI-DI code, and then the code with other data must be transferred to the UDI database. The UDI-DI code is a device-specific unique code that is also used as an "access key" to information stored in the UDI database. The data transferred to this database include, among others:

1. the method of controlling the production of the product,

2. quantity in one package configuration,

3. product risk class,

4. code in the nomenclature of medical devices,

5. manufacturer's data,

6. optional additional product description.

In addition to the UDI database, the EUDAMED system was also created, i.e. the European database on medical devices. The data is entered by individual Member States, notified bodies, economic operators and sponsors. It aims to enable:

1. duly informing the general public about products placed on the market;

2. unique identification of products on the internal market and facilitate their traceability;

3. to properly inform the general public about clinical trials and enable sponsors of clinical trials to meet the obligations set out in the Regulation;

4. producers to fulfill their information obligations;

5. competent authorities of the Member States and the Commission to fulfill their tasks related to this Regulation on the basis of complete information and to enhance cooperation between them.

Example 1.

A manufacturer involved in the production of medical equipment for patient diagnosis will have to comply with all obligations related to the regulation for the product to receive the UDI-DI code and can be properly identified.

Regulations for entrepreneurs in the medical market

The regulation quite clearly indicates the obligations of individual entrepreneurs, including manufacturers, importers and distributors. Their list for the above-mentioned entrepreneurs is very extensive and each company must prepare for major changes for the medical devices market (Articles 10-14 of the EU Regulation 2017/745).

The general obligations of producers include, for example:

1. design and manufacture of products in accordance with the regulation;

2. establishing, documenting, implementing and maintaining a risk management system;

3. conducting clinical evaluation, including post-marketing clinical follow-up;

4. updating technical documentation of products;

5. fulfilling obligations in connection with the UDI system and in the scope of registration.

A number of obligations will also apply to importers, who will be obliged to:

1. keeping a register of complaints about non-conforming products;

2. ensuring compliance of the product with general safety conditions during the product, storage or transport;

3. checking whether the product is registered in the electronic system;

4. checking whether the product has been affixed with the CE marking and the EU declaration of conformity has been drawn up;

5. check if the product is properly labeled.

As in the case of importers, distributors are required to control the marking of the product, including the affixing of the CE label, whether the product has been given a UDI code and whether the label contains all the information that the manufacturer of the product should provide.

Regulations for entrepreneurs of the medical market and market supervision

Each Member State will have specific bodies that will have the task of controlling the market for medical devices as well as their compliance, properties and performance. The authorities will have the right to review documentation and to carry out physical or laboratory tests on the basis of samples taken (Article 93 of EU Regulation 2017/745).

Due to their obligations, market surveillance authorities will be able to:

1. require economic operators, inter alia, to make available the documentation and information necessary for the purposes of activities carried out by these authorities and, in justified cases, to provide the necessary samples of devices free of charge or to grant access to devices;

2. carry out announced and, if necessary, unannounced inspections at the premises of economic operators and suppliers or subcontractors, and, if necessary, at the premises of professional users.

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Products with no intended medical purpose

Annex XVI to the Regulation lists products identified as not having an intended medical purpose. The provisions of this Regulation regarding non-medical devices cover at least the application of risk management and, where necessary, the issue of clinical safety evaluation (Article 1 (2) of EU Regulation 2017/745).

The groups of products that do not have the intended medical use are:

1. contact lenses or other items intended for insertion into or onto the eye;

2. products intended to be fully or partially introduced by invasive surgical means into the human body to alter anatomy or immobilize parts of the body, except tattoo and piercing products;

3. substances, mixtures of substances or articles intended for use in filling the skin of the face or other skin or mucosa by subcutaneous, submucosal or intradermal injection or other insertion, except those intended for tattooing;

4. equipment intended for use in the reduction, removal or destruction of adipose tissue, such as liposuction, lipolysis or lipoplasty equipment;

5. equipment emitting high intensity electromagnetic radiation (e.g. infrared, visible and ultraviolet light) designed for use on the human body;

6. equipment designed to stimulate the brain by means of electric currents or magnetic or electromagnetic fields.

Legal basis

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017