Certification of medical devices

“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.

Before placing a medical device on the market, manufacturers shall perform a conformity assessment of a medical device. This process shall be carried out by the manufacturer in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI of the Regulation (EU) 2017/745 on medical devices (MDR). Depending on the selected classification and conformity assessment route, Class Is, Im, Ir, IIa, IIb and III devices require an assessment of technical documentation by a notified body.

What is the Regulation (EU) 2017/745 of the European Parliament and of the Council?

Regulation 2017/745 is a legal act that governs the medical devices market to ensure the protection and safety of patients and users. At the same time, it sets high quality standards for medical devices.

This Regulation replaces the previously applicable Directive 93/42/EEC, which expired on 26 May 2021. The novelty is that devices without an intended medical use are covered by this legislation.

This means that certain groups of devices that do not meet the definition of a medical device are subject to the same requirements and restrictions as medical devices.

Validity of certificates issued under the Directive 93/42/EEC

The notified body TUV NORD Polska (No. 2274), designated in 2011, provided certification services of medical devices for compliance with the Directive 93/42/EEC until 26 May 2021. With the expiry of the aforementioned Directive, issued certificates remain in force until the expiry date stated on the certificate, but no longer than until 25 May 2024.

Pursuant to the Article 120 of the Regulation 2017/745, TUV NORD Polska shall supervise the certificates issued taking into account the additional requirements described in this article.

Is it possible to obtain a preliminary calculation before submitting the documentation to the notified body?

Before submitting an application, the client may ask the notified body to provide a preliminary cost calculation of the conformity assessment. To do this, please complete the application titled: General information about the products and send in PDF format.