Statements and Comnitments

The copy of National Court Register document or certificate of entry in the register of business activity

The written declaration that no application for product assessment has been submitted to another Notified Body

The written declaration that no medical incidents involving the medical device applied for certification have been occurred

The Manufacturer’s commitment to maintain the procedures of regular review of experience gained with the in vitro diagnostic medical device subsequent to its being placed on the market

The Manufacturer’s commitment to fulfil the obligations resulting from his Quality Assurance System

The Manufacturer’s commitment to maintain the effectiveness of the Quality Assurance System

The Manufacturer’s commitment to maintain the procedure in accordance with the chapter 9 of the Act on Medical Devices (the Polish Act) in case of receiving an information on medical incident

The Authorised Representative’s written statement about cooperation with Manufacturer (if applicable)

Technical documentation of the medical device

The description of the type of product including variants and the list of differences between variants

The essential requirements checklist (Annex 1 to the Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures of in vitro diagnostic medical devices as amended (Journal of Laws of the Republic of Poland 2016, item 211)

The design drawings, the specifications of components and parts, circuit diagrams

The results of the design calculations

Diagram of the manufacturing process including the mid-production inspection with indication of subcontracted stages

The list of harmonized standards applied in whole or in the part and other applied standards

Description of meeting the essential requirements, if they are not based only on the harmonized standards

Test reports showing conformity with requirements of harmonized standards and/or Common Technical Specifications

Performance evaluation data confirming parameters declared by the manufacturer

Stability testing data confirming the stability declared by the manufacturer

Report of testing with participation of non-professional users (if applicable)

Declaration of conformity of the in vitro diagnostic medical device

Risk management and risk analysis, including: Report of risk analysis for conformity with PN-EN ISO 14971/EN ISO 14971

A draft marking (label), package (in case of translation of information documents, a formal confirmation from translation agency shall be attached)

Instructions for use of a medical device (in case of translation of information documents, a formal confirmation from translation agency shall be attached)

Information on the in vitro diagnostic medical device restrictions

Information on the origin and conditions under which human tissues are derived or substances derived from these tissues - refers to medical devices containing human tissues or substances derived from these tissues

Brochures, folders, presentations and other promotional materials concerning in vitro diagnostic medical devices prepared by the Applicant (in case of translation of information documents, a formal confirmation from translation agency shall be attached)

List of all suppliers and subcontractors, indicating key critical suppliers/subcontractors; certificates of suppliers/subcontractors (if applicable)

Product sample to be consulted with the PCBC

Manufacturer Quality Assurance System documentation

Quality Manual + Quality Policy and Objectives

Organizational chart and responsibilities and competencies of the management

Document and record control procedure

Risk management procedure

Designing procedure

Manufacture procedure

Procedure for the purchasing and subcontractors’ control

Non-complying device control procedure

Corrective and preventive actions procedure

Servicing procedure (if applicable)

Sterilization procedure (if applicable)

In vitro diagnostic medical device identification and traceability procedure

Product security procedure

Measuring equipment supervision procedure

Procedure for obtaining the feedback from users concerning product (data analysis)

Procedure for the testing of in vitro diagnostic medical device during the manufacture process or/and testing of final product

Internal audit procedure

Product measurement procedure

Procedure for issuance and implementation of advisory notes

Procedure for dealing in case of medical incidents

Procedure for regular review of experience gained with the device subsequent to its being placed on the market