Clinical investigation - any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Performance study - a study undertaken to establish or confirm the analytical or clinical performance of a device.
National regulation on medical devices is the Regulations No.455 of the Cabinet of Ministers of Latvia, adopted August 15, 2023 “Procedures for conducting clinical investigations on medical devices and performance studies on in vitro diagnostic medical devices for human use”
The Regulation No.455 implements obligations of the Regulation (EU) 2017/745 on medical devices and 2017/746 on in vitro medical devices of April 5, 2017.
National regulation defines:
- the structure, functions, and procedures for delivering an opinion of the Ethics Committee,
- the procedures for the authorisation of a clinical investigation and performance study,
- the duties and responsibilities of the parties involved (sponsors, investigators),
- the protection of the subjects participating in a clinical investigation and performance study,
- the monitoring and reporting requirements.
Authorisation of clinical investigations and performance studies
The sponsor must obtain authorisation from the State Medicines Agency (SAM) for clinical investigations of medical devices and performance studies of in vitro diagnostic devices, except:
- in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices,
- in the case of performance studies carried in which surgically invasive sample-taking is done only for the purpose of the performance study and where the specimen collection does not represent a major clinical risk to the subject of the study.
Submission of documents
- the sponsor shall submit a clinical investigation application (application form) to the SAM, accompanied by the documentation referred to in Chapter II of Annex XV of the Regulation 2017/745,
- the sponsor shall submit a performance study application (application form) to the SAM, accompanied by the documents referred to in Sections 2 and 3 of Part A of Annex XIII and Annex XIV of the Regulation 2017/746.
- for a substantial modification of a clinical and performance study, the sponsor shall submit to the Agency a performance study application (application form), accompanied by an updated version of the relevant documentation.
Please use the following email address to submit your application: info@zva.gov.lv.
Payment procedure
Payment for the service should be made in accordance with the SAM Paid Service Pricelist:
- 1500,00 EUR for the first examination of clinical investigation documentation,
- 900,00 EUR for the examination of a substantial modification of clinical investigation.
Please submit a Payment application to the following email address rekini@zva.gov.lv. SAM will forward an invoice after submitting Payment application. Upon making the payment, please provide invoice number and date in the payment purpose section of the payment assignment.
Requisites
State Agency of Medicines of Latvia
Jersikas street 15, Riga, LV-1003, Latvia
VAT reg. No. LV90001836181
Riga settlement center of the Treasury
LV24TREL9290579005000
BIC TRELLV 22
Regulations and Guidelines
Regulations No.455 of the Cabinet of Ministers of Latvia, adopted August 15, 2023 “Procedures for conducting clinical investigations on medical devices and performance studies on in vitro diagnostic medical devices for human use”
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
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Medical Device Coordination Group (MDCG) guideline documents
Report forms
Serious Adverse Event Reporting Form
