IVDR
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This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products.

 

ANALYSIS

ISO 13485 QMS / KYS

Does your current quality management system meet IVDR requirements?

Do you have an existing quality management system, but have not been able to adapt it to new regulatory requirements?

 

EXCOPAN analyzes your current system for you and makes it ready for use by making all the arrangements in line with the deficiencies it has determined.

TECHNICAL DOCUMENTATION

Do you have an existing technical documentation, but have not been able to adapt it to new regulatory requirements?

EXCOPAN analyzes your current technical documentation for you and delivers a comprehensive report that will allow you to understand your shortcomings along with the reasons.

DIGITALIZATION

EXCOPAN enables the data and assets within the organization to be processed through advanced digital technologies that lead to fundamental changes in business processes that can result in new business models and social change, contributing to the adaptation of organizations to the new world order.

EFFICIENCY

Business efficiency refers to how much a company or organization can produce as it relates to the amount of time, money and resources needed.

 

EXCOPAN analyzes the process and operational efficiency within the organization, determines the requirements that will allow the processes to gain maximum efficiency with minimum impact, and offers solutions that will maximize the efficiency of companies.

STAFF QUALIFICATION

 

FINANCIAL QUALIFICATION

 

TECHNICAL DOCUMENTATION

Technical Documentation means documents that shows how each medical device was developed, designed and manufactured. Every medical device manufacturer should prepare the technical documentation of the products it produces, keep it up-to-date and integrate with the existing quality management system. 

 

Technical Documentation demonstrates that the medical device to which it applies conforms to the General Safety and Performance Requirements of 2017/746 IVDR.

Guiding information on what the technical documentation should contain is given in Annex II of the regulation 2017/746 IVDR.

  • Device description and specification, including variants and accessories (Regulation (EU) 2017/746 (IVDR), Annex II Section 1)

  • Information supplied by the manufacturer (Regulation (EU) 2017/746 (IVDR), Annex II Section 2)

  • Design and manufacturing information (Regulation (EU) 2017/746 (IVDR), Annex II Section 3)

  • General Safety and Performance Requirements (Regulation (EU) 2017/746 (IVDR), Annex II Section 4)

  • Benefit-Risk Analysis and Risk Management (Regulation (EU) 2017/746 (IVDR), Annex II Section 5 & 6)

  • Summary of Safety and Performance (SSP) (only class C and D devices) (Regulation (EU) 2017/746 (IVDR), Article 29)

TRACEABILITY

The IVDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of in vitro diagnostic medical devices that have been found to present a safety risk. The UDI and access to associated information on approved devices will be stored in the European Databank on Medical Devices (EUDAMED).

EUDAMED

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on in vitro diagnostic medical devices (Regulation (EU) 2017/746).

 

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU).  EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

 

EUDAMED will be composed of six modules related to: 

 

  1. Actor and User Registration and Management

  2. UDI Database and Registration of Devices

  3. Certificates and Notified Bodies

  4. Clinical Investigation and Performance Studies

  5. Vigilance and Post-market Surveillance

  6. Market Surveillance

UDI (UNIQUE DEVICE IDENTIFICATION)

Unique code allows to improve devices traceability and to make faster and more efficient a possible recall on products for which safety risks have been identified.

 

In accordance with the new rules, any manufacturer shall assign to the device and to all higher levels of packaging a UDI before placing a device on the market. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging.

 

Following a call for application launched at the end of 2018 and the Commission Implementing Decision (EU) 2019/939 of 6 June 2019, 4 issuing entities were designated to provide manufacturers with a list of UDIs to assign on medical devices.