Conformity assessment in the regulated field shall be carried out by conformity assessment bodies accredited in accordance with the regulatory enactments regulating a specific field (Conformity assessment bodies----shall notify the European Commission of the conformity assessment bodies that carry out conformity assessment in the regulated field.)

Annex II: technical documentation format

1.   Device Description And Specification, Including Variants And Accessories

2.   Information To Be Supplied By The Manufacturer

3.   Design And Manufacturing Information

4.   General Safety And Performance Requirements

5.   Benefit-Risk Analysis And Risk Management

6.   Product Verification And Validation

Annex III: Technical documentation on post-market surveillance

The Official Language Law lies down that for any imported devices, the labelling, instructions for use, guarantee documents or technical certificate which includes information in a foreign language, shall have attached thereto a translation of such information in Latvian language. If a foreign language is used concurrently with Latvian language, the text in Latvian language shall be placed in primary position, and it may not, in its form or contents, be smaller or narrower than the text in the foreign language.

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.

In order to receive a Free Sales Certificate, medicinal product manufacturer registered in Latvia submits to State Agency of Medicines (SAM) an application for issuance of a Free Sales Certificate.

Vigilance

A “Vigilance incident report”  must be submitted to the State Agency of Medicines (SAM) within three days after any incident or potentialincident related to the use of a medical device that has resulted in or may result in death or serious harm to the health of a patient, user or third person, and the manufacturer or authorised representative of the manufacturer, or distributor of the medical device must be informed. 

An initial report of the manufacturer regarding the incident with the medical device shall be sent to the State Agency of Medicines of Latvia not later than 15 days after the manufacturer become aware of the incident.

According to the Regulatio

Advertising objects with brands of manufacturers of medicinal products, medicinal products wholesalers, pharmacies, holders of registration certificates of medicinal products and tissue establishments, names and symbols of medicinal products and medical devices, advertising of medicinal products and medical devices, etc., shall not be used in the workplace, except in cases when such objects are necessary for the performance of direct duties (for example, examination of a submission received).