The first EUDAMED module, launched on 1 December 2020, is the electronic operator registration system. All economic operators (EU and non-EU manufacturers, authorized persons, systems & procedure pack kit producers, importers) must register with EUDAMED and provide the necessary information.

Economic operator registration process (excluding non-EU manufacturers)

1. Sending the application for registration – electronically
2. Assessment of the registration by the competent authority
3. Approval of registration – assignment of Single Registration Number
4. In case of non-approval by the relevant competent person
   • Invitation to complete the application and then approve the registration (point 3)
   • Rejection of the application for registration

For non-EU manfacturers, the procedure will be slightly different. Before the application is assessed by the competent authority, it will be necessary to verify the application by an authorized person. The authorized person must therefore already be registered with EUDAMED prior to this process.

Single Registration Number (SRN)

It uniquely identifies each economic operator in EUDAMED. SRN is issued as soon as the competent authority confirms the application for registration of the economic operator. Please note that the economic operator must register separately for each notified activity. Therefore, if the economic operator is both a manufacturer and an importer of medical devices, he will be assigned two registration numbers.

More information

The functionalities are launched for persons established in the EU (Iceland, Liechtenstein and Norway) and non-EU manufacturers having authorized persons in the EU (Iceland, Liechtenstein and Norway). For persons from other countries, the possibility of registration will be launched at a later stage (this also applies to persons established in Turkey and the United Kingdom).

Although registration in EUDAMED will be mandatory, registration is not currently required until EUDAMED is fully operational and other modules are launched (a brief overview of the modules is given in our previous news, European Databank on Medical Devices – EUDAMED). It is therefore possible that registration in national systems is still required.

If the economic operator already wants to register at the moment, he can use the services of MeDeCorp s.r.o., which will guide you through the registration process. What are the exact requirements for the registration of an economic operator, what are the necessary documents required and further detailed information about EUDAMED will be described in the next update.

Our services

If you need help to become familiar with the complex and changing issues of medical device legislation, do not hesitate to contact us by email: medecorp@medecorp.cz or via the Internet form at www.medecorp.cz. We will also be happy to help you, for example, with the placing of a medical device on the market, the creation of technical documentation or the comprehensive provision of regulatory affairs in your company. You can also find a list of services offered on our website.

On February 24, 2021, the company Dialab spol. s r.o. obtained the exception of placing a medical device on the market in the Czech Republic. This exemption concerns two medical devices that can be used for self-testing on COVID-19 and their use is in the interest of public health protection. The application submitted to the Ministry of Health of the Czech Republic was prepared by MeDeCorp s.r.o., which provides Dialab spol. s r.o. medical device management.

The exception applies to the following two medical devices:

• Flowflex SARS-CoV-2 Antigen rapid test
• Insert DIAQUCIK COVID-19 Ag Cassette

Our services

If you need to place medical device on the market, become familiar with the legislation of medical devices or need to provide comprehensive regulatory affairs in your company, do not hesitate to contact us by email: medecorp@medecorp.cz or via the online form at website www.medecorp.cz. Complete list of offered services can be found on our website. You can find a complete list of offered services on our website.

As part of the implementation of the requirements of the EU Regulation 745/2017 on medical devices and the EU Regulation 746/2017 on in vitro diagnostic devices, the EUDAMED information system was extended (this is a significantly more widespread database compared to the current version of the database). An important change is that some information from the EUDAMED database will be available to both professionals and the general public. Thanks to several interconnected modules, EUDAMED will promote better transparency and information in the field of medical devices. EUDAMED will serve several purposes. It will function both as a registration system for the relevant economic operators and as a system for notification and dissemination of information.

The system will consist of several interconnected systems:

• electronic system for registration of economic operators,
• electronic system for registration of funds,
• UDI database,
• electronic system for notified bodies and certificates,
• electronic system for clinical trials,
• an electronic system for post-market vigilance and monitoring,
• an electronic system for market surveillance.

At present, only the economic operator registration system is up and running. In May 2021, the launch of an electronic system for the registration of funds and the UDI database is planned. The full launch of all functionalities will take place in May 2022, together with the effectiveness of EU Regulation 746/2017 on in vitro diagnostic devices.

We will describe which economic entities are obliged to register in the EUDAMED system and how this process takes place in the next update.

Our services

If you need help to become familiar with the complex and changing issues of medical device legislation, do not hesitate to contact us by email: medecorp@medecorp.cz or via the Internet form at www.medecorp.cz. We will also be happy to help you, for example, with the placing of a medical device on the market, the creation of technical documentation or the comprehensive provision of regulatory affairs in your company. You can also find a list of services offered on our website.

On October 12, 2020, we participated as a lecturer in a symposium – Medical Technology in the Light of Legislative Changes and in a Time of Emergency. The event was organized by the Aesculap Academy (educational services provided by B. Braun Dialog) in cooperation with the Czech Society for Medical Technology in the premises of the B. Braun Dialog Pavilion in Prague 8. The symposium was focused on sharing the experience of experts from practice and experts from professional circles with representatives of hospitals.

Content of lectures:

• Ing. Vojtech Kamensky
  • New changes in medical device legislation
• Ing. Ondřej Gajdoš
  • Post-market monitoring of medical devices

The end of the deadline for notification of the medical devices is approaching

Dear Distributors and Suppliers of Medical Devices, with the adoption of the new Act No. 268/214 Coll., On Medical Devices and amending Act No. 634/2004 Coll., On Administrative Fees, the agenda for the notification of medical devices was transferred to a new unified system for complex data management in the field of medical devices. The Medical Device Register (RZPRO) serves to collect data on:

• persons registered under this Act,
• medical devices placed on the market in the Czech Republic,
• adverse events and safety remedial measures,
• clinical trials of medical devices,
• performed assessments of the functional capability of medical devices and
• certificates issued by Notified Entities established in the Czech Republic.

We would like to draw your attention to the termination of the transitional provision concerning medical devices of Class IIa, which is referred to in Section 97 of the Transitional Provisions in paragraph:

(5) Distributor or importer who has fulfilled his obligation of reporting pursuant to Act No. 123/2000 Coll. and intends to continue to place on the market in the Czech Republic a medical device which it introduced or supplied to the Czech Republic before the date of entry into force of this Act and which is subject to notification under § 33, it is obliged to submit a request for notification of this medical device at the latest to

1 year after the effective date of this Act in the case of a Class III medical device or an active implantable medical device,
2 years from the effective date of this Act in the case of a Class IIb medical device or an in vitro diagnostic medical device belonging to List A or B,
3 years from the effective date of this Act in the case of a medical device of Class IIa or a self-testing medical device
(6) The application submitted pursuant to paragraph 5 shall be decided by the Constitution no later than 90 days from the date of filing the application.

Since Act No. 268/214 Coll. on medical devices acquired pursuant to Section 104 effective on April 1, 2015, expires the validity of the notification of the Class IIa medical device on 1 April 2018. It is therefore necessary to submit an electronic application for the extension of the notification of the medical device through the register of medical devices before the expiry of this period.

We will be happy to assist you with the whole agenda of extending the notification of medical devices. In addition, we can provide you with a follow up of the expiration of the notification period of medical devices with your other medical devices so that you can meet all the required legislative requirements smoothly.

Best regards, MeDeCorp s.r.o.