Articles

New regulation in relation to the medical device’s distributors

by Andrea Obuchová

As of 26.5.2020, a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“Regulation”) becomes effective. Until then, the current national regulation under the Act no. 362/2011 Coll. on Drugs and Medical Devices as amended (“Act on Drugs and Medical Devices”) applies, however this fails to regulate the rights and obligations of distributors, but instead, focuses primarily on the person of manufacturer.

The obligations of distributors under the Regulation 

A distributor is considered any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service. 

When making a device available on the market, the distributors shall, in the context of their activities, act with due care. The Regulation describes the responsibilities of the distributors, who should ensure that the devices they distribute comply with the requirements described therein.

The distributors shall under the Regulation:

  • verify that devices bear the CE marking, that an EU declaration of conformity has been drawn up, that the importer's name appears on each device and in the accompanying documentation and that the device has an UDI (Unique Device Identification) identifier;
  • ensure that the medical device is made available to the user or patient and is accompanied by the information (labels and instructions for its use) provided in the national language;
  • ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer;
  • in cases where a distributor considers or has reason to believe that a device is not in conformity with the requirements of the Regulation, it shall not be made available on the market and the distributor shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer;
  • inform the competent authorities in case the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device;
  • in cases where a receipt of complaints or reports from healthcare professionals exists, patients or users about suspected incidents related to a device they have made available, immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer;
  • keep records of complaints, of non-conforming devices and of recalls and withdrawals;
  • cooperate with the authorities and make available all documentation and information available to them.

Further obligations under the Act on Drugs and Medical Devices as of 26.05.2020

A distributor who has made a medical device available on the Slovak market shall notify the State Institute for Drug Control in writing within 14 days of making the medical device available on the market by submitting a standardized form, EU declaration of conformity, certificates of conformity assessment, outer packaging and instructions for use, the name, the address of the place of business or the address of the registered office, the name and address of the registered office of the manufacturer, the name and address of the registered office of the authorized representative and the name, class of the medical device made available on the Slovak market. This documentation and information must be provided in national language.

The State Institute for Drug Control may request a distributor who has a place of business in the Slovak Republic to provide samples of the medical device free of charge or, if this is not possible, to allow access to the medical device. 

If the distributor does not cooperate or if the information or documentation provided is incomplete or incorrect, the State Institute for Drug Control may, in order to ensure public health and patient safety, prohibit the medical device from being made available on the Slovak market, order the medical device to be recalled or withdrawn until the distributor cooperates or provides complete and correct information.

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