Law No. 21/2020 dated 05.03.2020 “On some amendments to Law No. 89/2014 “On Medical Devices”
Law No. 21/2020 dated 05.03.2020 “On some amendments to Law No. 89/2014 “On Medical Devices”
The Albanian Parliament has adopted the Law No. 21/2020 dated 05.03.2020 “On some amendments to Law no. 89/2014 “On Medical Devices” (“The Law”).
The Law is published in the Official Gazette no. 54 dated 31.03.2020. It is partially aligned with Regulation (EU) 2017/745 of the European Parliament and of the European Council of 5 April 2017, “On medical devices, amending Directive 2001/83/ EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repeals Council Directives 90/385 / EEC and 93/42 /EEC”.
The Law aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users. At the same time, this Law sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.
The Registration Process
All medical devices defined by the Law which are classified in different categories (i.e. Classes) for purposes of placement into the Albanian market shall be registered at the National Register of Medical Devices kept by the National Agency of Medicines and Medical Devices.
The registration is carried out by the manufacturer or the manufacturer’s representative in the Republic of Albania or the wholesaler, upon the authorization of the manufacturer.
The registration certificate is issued by the National Agency for Medicines and Medical Devices in a timely manner depending to the category of the medical devices (i.e., from 5 to 30 working days from the application date).
The registration certificate is valid for a period of 5 years from the date of its issuance.
Labeling and Instructions for Use
Every medical device that is placed into the market and put into service must contain the label in the Albanian language, which must be presented in a visible and readable form.
The rules on labeling and instructions for the use of medical devices shall be adopted upon decision of the Council of Ministers.
Manufacture of Medical Devices
It is the Minister in charge for health that approves the manufacturing of medical devices by licensed entities. The proposal for the granting of the approval for manufacturing is submitted to the minister by the Commission for Verification of Conditions of Production.
The Commission for Verification of Conditions of Production of Medical Devices is established upon the order of the Minister responsible for health.
The licensing requirements shall be determined upon decision of the Council of Ministers. The latter shall also determine the storage and transportation requirements.
Advertisement of the medical devices
The advertisement of medical devices shall be subject to a decision of Council of Ministers depending to the characteristics of the medical devices.
Advertisement of medical devices shall exclude any information that:
- describes functions and features of the devices which the devices do not actually have;
- creates a false impression about treatment, diagnosis, functions or features that the devices do not have;
- fails to inform the user or the patient of a potential risk associated with the use of the devices, as indicated by it;
- suggests use of the devices, other than those for which conformity assessment has been obtained and which serves the purpose of the devices.
E-Commerce
The wholesalers and retailers of medical devices may purchase and sell them through the Internet in accordance with the rules set forth in this Law and other applicable legislation.
Wholesalers and retailers of medical devices shall communicate, in advance, to the National Medical Devices Agency the necessary information on the devices they will trade online.
The order setting the criteria for the wholesale or retail sale of medical devices in the internet shall be approved by the Minister responsible for health.
Devices Presenting a Health and Safety Risk
The competent authority, where it finds that a medical devices placed into the market poses a risk to the health or safety of patients, users or other persons, shall require the manufacturer of the relevant devices or its representative to take action and bring the devices in accordance with the requirements of this law, restrict the placing on the market of the devices, return it or remove the devices from the market within a reasonable period, clearly specified and communicated to the manufacturer / devices representative. Medical devices, during their life cycle, are subject to periodic checks by specific authorities to ensure the quality and operation, as specified in the order of the Minister responsible for health.
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