What is IVDR?

The IVDR (In Vitro Diagnostic Regulation (EU) 2017/746) is a European Union regulation that governs the requirements for in vitro diagnostic (IVD) medical devices. It outlines the standards for safety and performance that IVD devices must meet before they can be placed on the market in the EU. IVD devices are tests performed on biological samples (e.g., blood, tissue) to diagnose diseases or other conditions. The IVDR replaces the previous IVD Directive (IVDD) and introduces stricter requirements for manufacturers, including increased scrutiny of device performance, traceability, and post-market surveillance.

Find 229 organizations using IVDR on Sumble →

What other technologies are related to IVDR?

IVDR Competitor Technologies

M

MDR

The Medical Device Regulation (MDR) is a regulation related to medical devices, while IVDR relates to in-vitro diagnostic devices. Although they are separate regulations, they both govern the medical device industry and serve a similar purpose, making them competitors in terms of regulatory focus and resource allocation for manufacturers.

Number of organizations that mention technology

ⓘ Tap on a tech to explore matching organizations

IVDR Complementary Technologies

ISO 13485

ISO 13485 specifies requirements for a quality management system specific to the medical device industry. It is often used in conjunction with regulations like IVDR to demonstrate compliance and ensure product quality and safety, acting as a complementary standard.

MDSAP

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to be audited once for compliance with the regulatory requirements of multiple countries. While not specific to IVDR, it offers a streamlined approach to demonstrating compliance with various regulatory requirements, including those relevant to IVDs, making it complementary.

ISO 14971

ISO 14971 specifies requirements for applying risk management to medical devices. It is a crucial standard used in conjunction with IVDR to ensure that risks associated with IVDs are appropriately identified, evaluated, and controlled, therefore it acts as a complementary standard.

Number of organizations that mention technology

ⓘ Tap on a tech to explore matching organizations

Which job functions commonly mention IVDR?

Public Policy

0.1% of all Public Policy jobs mention IVDR

View 131 jobs on Sumble

Bioinformatician

0.1% of all Bioinformatician jobs mention IVDR

View 3 jobs on Sumble

Quality Engineer

42 Quality Engineer jobs mention IVDR

View 42 jobs on Sumble

Quality Assurance

103 Quality Assurance jobs mention IVDR

View 103 jobs on Sumble

Operations

118 Operations jobs mention IVDR

View 118 jobs on Sumble

See more or filter by date, location, industry, etc →

Which organizations are mentioning IVDR?

BSI

Professional Services

Agilent Technologies

Scientific and Technical Services

bioMerieux

Manufacturing

Thermo Fisher Scientific

Scientific and Technical Services

QuidelOrtho Corporation

Manufacturing

See more or filter by date, location, industry, etc →

Summary powered by

Sumble

Find the right accounts, contact, message, and time to sell

Whether you're looking to get your foot in the door, find the right person to talk to, or close the deal — accurate, detailed, trustworthy, and timely information about the organization you're selling to is invaluable.

Use Sumble to:

Sign in to continue exploring

or

Book a call to discuss your needs

**IVDR**

What is IVDR?

What other technologies are related to IVDR?

IVDR Competitor Technologies

IVDR Complementary Technologies

Which job functions commonly mention IVDR?

Which organizations are mentioning IVDR?

Find the right accounts, contact, message, and time to sell

IVDR