Skip to content
menu-icon-lq
close-icon-lq
Technical documentation
QA/RA Services

Qualification and classification of medical devices

The qualification of a device as a medical device or an in vitro medical device is first established in the regulatory plan created for the device. The qualification is justified based on the definition of a medical device as set out in Article 2 of MDR (2017/745) and the definition of an in vitro medical device set out in Article 2 of IVDR (2017/746).

Clarity to the classification complexity

It is important to determine a correct risk class for the device as the risk class determines the applicable conformity assessment procedure required for regulatory submission. The classification of the device is based on its intended purpose. Annex VIII of both MDR (2017/745) and IVDR (2017/746) define the rules for device classification.

labquality-frame-green (2)

Labquality

How can we help?

Even though some guidance has been provided for interpreting the classification rules, the classification of a device can sometimes be complicated. Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Meeri Säily

Contact us for more information

user
Meeri Säily
Sales Director, Consulting and Clinical Trials
contact-email
meeri.saily@labquality.com

Leave a contact request

Related Services

Electrical Safety IEC 60601
Technical documentation

Electrical Safety IEC 60601

IEC 60601-1 is the basic safety standard for medical electrical devices and systems.

Read more
Biological Safety ISO 10993
Technical documentation

Biological Safety ISO 10993

We provide medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation.

Read more
IVD Performance Evaluation
Technical documentation

IVD Performance Evaluation

Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation.

Read more
Risk Management ISO 14971
Technical documentation

Risk Management ISO 14971

Labquality provides medical device manufacturers help in setting up and implementing a risk management system and preparing risk management documentation.

Read more
Regulatory plan
Technical documentation
Global Registrations
QA/RA Services

Regulatory plan

Labquality can help medical device manufacturers in creating a regulatory plan.

Read more
IVDR compliance for in-house developed tests
Technical documentation
QA/RA Services

IVDR compliance for in-house developed tests

Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.

Read more
For Startups, Incubators and Institutions
QA/RA Services

For Startups, Incubators and Institutions

Regulatory compliance is a struggle for Health Tech innovators and startups where ever you go.

Read more
EU MDR and IVDR
QA/RA Services
Auditing services

EU MDR and IVDR

Labquality provides medical device manufacturers help with understanding the changing regulations that set the standards of quality and safety of medical devices.

Read more
Medical software
Technical documentation
QA/RA Services

Medical software

Labquality also provides comprehensive support for medical software lifecycle.

Read more

Latest news

01/11/24 09:00

New EQA schemes for 2025

Introducing our new EQA schemes for 2025!
Read more
17/09/24 06:30

Patient Safety: The Cornerstone of Healthcare

Learn how Labquality supports patient safety in healthcare through external quality assessments, clinical trials, medical device safety, and training to ensure high standards in patient care.
Read more
10/09/24 14:00

Labquality Days 2025 program published

The scientific program for the 2025 congress has now been published!
Read more
03/09/24 08:00

EQA Program 2025

The 2025 EQA program has now been published!
Read more
30/08/24 11:19

Does your device require a clinical investigation?

Clinical investigations are mandatory for certain medical devices in the EU. But how to know if your product requires a clinical study? Visit our blog to find out.
Read more

Subscribe to our newsletter

Subscribe to hear the latest news in the industry and keep track of what's happening behind the scenes.