Clinical evaluation of Medical Devices
Information for sponsors established outside the territory of the Czech Republic
The sponsors established outside the territory of the Czech Republic are highly recommended to consider cooperation with CROs established in the Czech Republic. Such cooperation might contribute to speeding up the processing of applications for authorisation of clinical investigation (CI) conduct and applications for clinical investigation change.
- The sponsor of the clinical investigation conducted at a provider’s of healthcare services established within the territory of the Czech Republic shall notify the Institute of its operation as a person handling medical devices. The operation of sponsor is notified via the Registry of Medical Devices (RZPRO). The sponsor is identified as notifier of the application for CI authorisation conduct within RZPRO.
- Another person (e. g. CRO) may be authorised to file a notification or application via the Registry of Medical Devices. Such person i is identified as agency within RZPRO. The assignor may grant and the assignee may accept the power of attorney also in electronic format via the RZPRO.In case, the power of attorney has been granted to the agency, the agency is considered the applicant. Communication within the procedure is conducted with the applicant. In case, the power of attorney is not granted by the sponsor to the agency, the sponsor is considered both a notifier and applicant.
- The application for authorisation of clinical investigation conduct shall be submitted by the applicant electronically, via the RZPRO.
Administrative procedure regarding the application for authorisation of CI conduct shall commence on the day when the application is delivered to the State Institute for Drug Control. Communication within the procedure shall be carried out and documents shall be executed in the Czech languace according to Section 16, paragraph 1 of the Administrative Code. A written document within the procedure shall be delivered by means of a public data network into the data mailbox set up according to Act No. 300/2008 Coll., on Electronic Acts and Authorised Document Conversion. Addressees established abroad may be delivered via a postal service operator, which is usually very time consuming.
Follow the instructions:
- The sponsor shall notify its operation according to Section 26, paragraph 5 of the Act on MD. The process is described in Manual No. 1
- The CRO applies for the access to RZPRO as Agency. Once, the access for CRO has been granted, it is followingly granted the power of attorney by sponsor electronically via RZPRO. The process is described in Manual Agency – request for access and power of attorney
- Once the operation of sponsor is notified and power of attorney to CRO granted the application for authorisaton of CI conduct may be submitted. The process is described in Manual No. 4
Update: February 2nd, 2021
As Regulation (EU) 2017/745 of the European Parliament and of the 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 repealing Council Directives 90/385/EEC and 93/42/EEC (further referred to as “MDR”) approaches, the Medical Devices Branch informs about changes that will be reflected in the agenda of clinical investigations of medical devices authorisation.
The effects of the transitional provision of Article 120(11) of MDR:
„Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2021 may continue to be conducted. As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.“
This transitional provision implies that all clinical investigations authorised by the Institute under existing legislation must be commenced before the date of application of MDR, i.e. May 25, 2021 at the latest. It is therefore important that sponsors of clinical investigations who shall submit an application for authorisation to conduct a clinical investigation under the Act No. 268/2014 Coll., on Medical Devices (further referred to as " Act on MD") in the upcoming months are aware of this fact. After the date, it will no longer be possible to commence a clinical investigation authorised under the Act on MD. The above mentioned is also set out in Section 72 par. 2 of the drafted new Act on medical devices and on amendments to Act No. 378/2007 Coll., on Pharmaceuticals, as amended (further referred to as” New Act on MD”).
“Clinical investigations authorised under Act No. 268/2014 Coll., as amended before the effective date of this Act but not commenced before the effective date of this Act, shall be deemed to be unauthorised”
At the same time, along with the transitional provision of the draft New Act on MD, the Medical Devices Branch draws attention to the obligation of the sponsor according to Section 19 para. 2, letter i) of the Act on MD, forthwith to notify the Institute about the commencement of the clinical investigation. Such notification shall be submitted via the Registry of Medical Devices (further referred to as “RZPRO”). By not reporting the commencement of a clinical investigation, the sponsor commits an administrative offence in accordance with Section 81 para. 4 of the Act on MD.
The Medical Devices Branch highlights that clinical investigation may be commenced only after the Decision on clinical investigation authorisation has acquired legal force.
An application for authorisation of the clinical investigation under the Act on MD is recommended to be submitted by February 28, 2021 at the latest and an application to amend the conditions of the clinical investigation by March 31, 2021, so that the Institute is able to assess the submitted dossier and the clinical investigation may be commenced within the date of application of MDR.
The above dates have been recommended based on the experience with the time required for the clinical investigation dossier assessment, which may include the requirement for dossier completion. When new versions of documents are created, the opinion of the relevant ethics committee on new versions of the documents is required and this may extend the total period until the Institute's decision issuance, even though the Institute proceeds within the statutory deadlines.
Applications for CI authorisation after the date of application of MDR
After the date of MDR application, the application for clinical investigation authorisation shall be submitted by means of the electronic system EUDAMED according to MDR. Based on the notification of the European Commission dated October 30, 2019, EUDAMED will only go online once the whole EUDAMED system was audited and declared fully functional. A new potential date for the first EUDAMED release was indicated as May 2022. As of the date of application of MDR until the launch of fully functional EUDAMED, the applications for clinical investigation according to Article 62, 74 (2) and 82 of MDR, applications for modifications to a clinical investigation and severe adverse event reporting shall be submitted via RZPRO, that has been launched according to the Act on MD.
As of the date of application of MDR, applications for clinical investigation will be submitted and assessed in accordance with Article 70 and Article 74 and Annex XV, Chapter II of MDR. Substantial modification to the clinical investigation will be submitted and assessed in accordance with Article 75 and Annex XV, Chapter II of MDR even in Clinical investigations authorized according to Act on MD. Similarly, severe adverse events will be reported in accordance with MDR. Deadlines for assessing applications will result from MDR and the New Act on MD.