Call: +48 785 062 202
pl en de
Flaga UE
Eubioco Logo

Placing medical devices on the market

04 Jan, 2022

To ensure the complete safety of all future users, before placing a medical device on the market, it must undergo a series of tests, procedures, and formalities. What does this path look like? Check what happens to this type of product during contract manufacturing of medicines, i.e. before they reach pharmacies, and what are the manufacturers’ obligations in light of the MDR regulation.

Introducing a medical device to the market – what conditions must the product meet?

Before a medical device is placed on the market, the manufacturer must ensure that it meets all the conditions described in the legal regulations related to its placing on the market.

The entity responsible must ensure that the product to be placed on the market:

  • meets all the specified requirements for product design, the entire manufacturing process, packaging design and all information on it, and product labeling;
  • has a correctly prepared certificate of conformity;
  • has been CE marked; has been fully tested and is safe for the life and health of future users;
  • does not exceed the limits of acceptable risk for medical devices;
  • has clearly defined functions, purpose, mode of action, and the possibility of adverse reactions;
  • all instructions and information materials for the user are clear, not misleading, do not leave room for misinterpretation, and do not conceal or omit important facts;
  • has a specified product shelf life that guarantees the safety of use before it is exceeded;
  • the manufacturer and authorized representative of the product are correctly and visibly indicated (in the instructions and labeling);
  • none of the product certificates have been withdrawn, suspended, or expired.

What are the manufacturer’s obligations?

  • manufacturer (before MDR referred to as the manufacturer) – currently has the most obligations of all entities in the supply chain, as it must:
    • ensure the product’s compliance with the MDR regulation;
    • ensure the product’s compliance during storage and distribution;
    • ensure compliance with other regulations;
    • provide financial coverage in case of legal liability;
    • supervise the product after it is placed on the market;
    • maintain a register of complaints and cases of withdrawal from use/circulation;
    • register the product in the EUDAMED database.

In the case of a process such as contract manufacturing, the manufacturer of the product is the company responsible for its manufacture, e.g. Eubioco

MDR also defines obligations for other entities in the supply chain, such as:

  • authorized representative,
  • distributor,
  • importer.

Details can be found in the MDR regulation.

Conformity assessment procedure

With the entry into force of Regulation (EU) 2017/745 of the European Parliament and of the Council, the conformity assessment procedure, which every medical device must undergo before being placed on the market, has changed.

The conformity assessment consists in checking whether all the requirements specified by law have been met by the manufacturer. In the case of class I devices, the manufacturer can independently carry out the conformity assessment, issue a declaration, and affix the CE mark to its product. All higher classes of the product must be assessed by a notified body – this can be any selected unit. What changes related to the MDR certificate affect manufacturers and distributors the most?

What has changed after the introduction of new legal regulations. Medical Device Regulation MDR

  • The scope of application of the regulations has been extended – it also covers non-medical devices.
  • Every medical device must have its own unique product number, i.e. UDI – Unique Device Identification.
  • The requirements for maintaining technical documentation (TD) have increased.
  • The requirements for conducting clinical trials have also increased – data is to be collected even after the medical device is placed on the market.
  • People responsible for placing new products on the market must have specialist knowledge of medical devices.
  • A new procedure for controlling high-risk class medical devices has been created – a double safety mechanism consisting of a clinical consultation procedure before placing on the market and control of conformity assessment after placing on the market.
  • The issue of notified bodies has been regulated in more detail.
  • For better, more transparent cooperation, a Europe-wide database has been created – EUDAMED.

What must the MDR certificate of the product contain?

  • name and number of the notified body that issued the certificate (in accordance with the current list of units to choose from),
  • number allowing to identify the certificate,
  • name and address of the manufacturer,
  • data identifying the certified product (including UDI),
  • description of the conformity assessment procedure carried out,
  • conclusions that appeared during the conformity assessment of the product,
  • defining the conditions and the date from which the certificate is valid,
  • seal and signature of the person authorized to issue the certificate.

Remember! After May 26, 2024, it will no longer be possible to sell or offer customers products placed on the market with the older directive (MDD).

Notification of the medical device to the relevant Office

Within 14 days of the conformity assessment, the device must be notified to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The President of the Office for Registration – if any conditions are not met – may reject the application.

In exceptional situations, the President of the Office for Registration may allow a device that has not yet undergone the conformity assessment procedure to be placed on the market. This may happen if the device is necessary for prophylactic, diagnostic or therapeutic purposes, or its use is justified by the need to save a person’s life or to protect public health in general. However, these are extremely rare cases.

Legal basis