Scribd
Upload
12 views1 page

Understanding MDR 2017/745 Compliance

The Medical Device Regulation (MDR 2017/745) introduces significant changes for medical device manufacturers in the European market, replacing the previous Medical Device Directive 93/42/EEC. It defines medical devices broadly and includes specific products that require CE Marking, emphasizing compliance throughout the product lifecycle. DQS Inc. collaborates with DQS Medizinprodukte GmbH to provide MDR certification services.

Uploaded by

4821888
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
12 views1 page

Understanding MDR 2017/745 Compliance

The Medical Device Regulation (MDR 2017/745) introduces significant changes for medical device manufacturers in the European market, replacing the previous Medical Device Directive 93/42/EEC. It defines medical devices broadly and includes specific products that require CE Marking, emphasizing compliance throughout the product lifecycle. DQS Inc. collaborates with DQS Medizinprodukte GmbH to provide MDR certification services.

Uploaded by

4821888
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

MDR

Medical Device Regulation (MDR 2017/745)

DQS MANAGEMENT SYSTEMS SOLUTIONS | 1 5 0 0 M CCO N N O R PA R KWAY S U I T E 4 0 0 | SCHAUMBURG, IL 60173 | 800-285-4476 | [Link]

The Medical Device Regulation (MDR) will bring


substantial changes to the way medical device
manufacturers bring their devices to the European
market and how they maintain compliance
throughout the product’s life cycle.
MDR replaces the Medical Device Directive 93/42/EEC (MDD,) which was
established in 1998 to harmonize the regulatory requirements for medical devices
in the European Union. An amendment came in 2007, which clarified what
products were considered medical device, due to continual advancements in
technology and development of international initiatives. It became mandatory on
March 21, 2010. The new European MDR began a three-year transition period in
May 2017.

What is Products are Considered Medical Device?

Medical devices under this directive are defined as any instrument, apparatus,
appliance, software, material, or other article intended by the manufacturer to be
used for human beings for the purpose of:
Quick Facts about DQS Inc.:
• Diagnosis, prevention, monitoring, treatment, or alleviation of disease

• Formed with a partnership


• Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or
between Underwriters
handicap
Laboratories Inc. (UL) and
DQS (German Registrar of • Investigation, replacement, or modification of the anatomy or a physiological
Management Systems). process control of conception and which does achieve its principal intended
DQS was founded by DGQ action by pharmacological process, immunological or metabolic means but
(German Society of Quality) may be assisted in its function by such means
and DIN (German Institute of
standardization). The new regulation also specifies particular types of products that also qualify as
medical devices requiring CE Marking.
• Global presence: 80 offices in
60 countries
• Products intended for cleaning, disinfection, and sterilization of medical devices
• Best in class auditors: over 2,500
• Devices for the control and support of conception
competent auditors worldwide

• Large customer base: over DQS USA partners with DQS Medizinprodukte GmbH (DQS Inc.’s holding) to offer
59,000 certifications MDR.

MAJOR DQS
D Q S Inc. SHAREHOLDERS

You might also like