Medical Device Regulatory Services

DEKRA provides you with evaluation assessment and certification services for the healthcare and medical devices industries

You are here

Home / Solutions / Certification & Market Access / Medical Device Regulatory Services

  • Ensuring safe medical devices for global markets

    As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market. At DEKRA, our vision is to be the global partner for a safe world. International standards and European directives are there to ensure that products are safe and function accordingly.

    It is essential that your Notified Body has the capabilities and expertise to support you with robust product certification and system certification reviews to ensure patient and user safety. We are active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices.

    Request a quote

    +31 88 96 83005

    medical.global@dekra.com

    Selected recognitions

    • MDSAP Recognized
    • AIMDD
    • MDD
    • MDR
    • IVDD
    • IVDR
    • ISO 13485 (RvA): certificate C589 and scope
    • Taiwan - TCP

  • Why DEKRA?

    Europe

    European Notified Body

    We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices

    Recognized

    Recognized auditing organization for MDSAP

    The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. DEKRA is a recognized auditing organization for MDSAP.

    Globally recognized

    Globally recognized certification body

    With a global network of offices and state-of-the-art laboratories, we can help you to gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan.

  • With the United Kingdom (UK) leaving the European Union (EU), changes came into force for manufacturers placing products on the UK market. As of January 1, 2021, a new conformity assessment marking scheme - called UK Conformity Assessed (UKCA) marking - was launched in Great Britain (England, Wales and Scotland) in place of the CE-mark. DEKRA is committed to continue its services to customers, for example manufacturers of Medical Devices active in the UK and has started the process to become a UK Approved Body. For more information and updates about UKCA marking and our process in becoming a UK Approved Body, please visit our webpage UKCA Marking services at DEKRA.

    In addition to being a designated European Notified Body, we are also a recognized MDSAP auditing organization. For an overview of our recognitions and scope, click here. We offer all the essential services to manufacturers of medical devices: MDR, AIMDD, MDD, IVDD, IVDR, MDSAP.

    Besides certification we also offer other services, such as electrical safety testing, EMC testing, wireless testing and international market access.

    For more information:

    PDF icon Program requirements QMS auditing services, DEKRA Certification B.V. 175 KB
  • Our services in detail:

    Medical Device Directive (MDD)

    Manufacturers of medical devices have a tremendous responsibility to keep end users safe. Therefore they need to comply with European regulations (93/42/EEC) to ensure that their innovative and continuously developed devices are safe and perform well. DEKRA is designated to review the compliance of products to the essential requirements of the MDD for access to the EU market.

    Transition from MDD to MDR
    The current MDD is being replaced by the Medical Device Regulations (MDR) which came into force on May 25, 2017. The transitional period will end in 2021. The scope of the MDR has been extended to include additional devices. 

    Medical Device Directive (MDR)

    This new Regulation brings a lot of changes. That is why it is important for all actors to be aware of the new requirements, and to prepare for and implement the new Regulation as soon as possible.

    The outlines  of the new Regulation:

    • Access for medical devices to the European market will become stricter and also requirements for manufacturers, importers and distributors and Notified Bodies will be expanded and reinforced:  Sharp demands on clinical evidence, especially for high-risk products, More stringent pre-market monitoring for high-risk products, Clear responsibilities for all economic participants
    • More transparency for patients
    • Better traceability of devices
    • Changes to classification rules meaning more devices are now in higher risk categories
    • Medical devices in a higher risk category must meet more stringent requirements in order to qualify for marketing authorization.

    Overall the intention of the new regulations is to ensure better protection of public health and patient safety. DEKRA is designated to review the compliance of products to the essential requirements of the MDR for access to the EU market.

    MDR: Frequently asked questions

    We rarely get as many questions about a topic as we do about the Medical Device Regulation (MDR). In our FAQ, you will find the answers to the questions we get time and again. Check it out frequently, because we will add more questions and answers to them from our experts.

    Open FAQ about MDR

    MDR Article 117

    The Medicines Directive 2001/83 has been significantly amended by the new Medical Device Regulation (MDR 2017/745). If you are a manufacturer of drug-device combination products regulated as medicinal products under Medicines Directive 2001/83 you need to be aware of Article 117 of the new regulation.

    Visit the Article 117 page

    In vitro Diagnostics Directive (IVDD)

    In vitro diagnostic devices are used to test tissue samples or bodily fluids. All in vitro diagnostic (IVD) devices sold in the European Union need to have a CE marking. The main objective of this is to make sure patients and users can rest assured that the products are safe for use. With the mark, the manufacturer shows that a device complies with all the relevant regulations. IVD devices are becoming more complex due to technological developments and other improvements. By conforming to the IVDD, the devices remain safe for use on patients even during times of continuous innovation. DEKRA has been officially designated to review the compliance of products to the essential requirements of the IVDD for access to the EU market.

    Transition from IVDD to IVDR
    The IVDR regulation was published on May 25, 2017, and the transitional period will run until 2022. The scope of the IVDR has been extended to include additional devices. 

    In-vitro-Diagnostic Medical Device Regulation (IVDR)

    The aim of this new regulation is to ensure better protection of public health and patient safety. Access for IVDs to the European market will be more stringent and the requirements for manufacturers, importers and distributors as well as notified bodies will be expanded and strengthened. Manufacturers of In-vitro-Diagnostics need to comply with European regulations to ensure that their innovative and continuously developed IVDs are safe and perform well. DEKRA is designated to review the conformity assessment to the European regulations for access to the EU market.

    DEKRA has two Notified Bodies for the EU In-vitro-Diagnostics Regulation (2017/746, IVDR):

    • DEKRA Certification GmbH (NB 0124) which was in October 2019 the first designated Notified Body in Europe for the Regulation and
    • DEKRA Certification B.V. (NB 0344) which received its designation in June 2021.

    DEKRA is active nearly everywhere in the world and the members of our in-vitro-diagnostic medical devices certification team have extensive expertise in a wide array of in-vitro-diagnostic devices.

    If you want to send us an application, please fill in our quote request form.

    You can also watch our webinar where we discuss the most important topics related to the new IVDR.

    Watch this webinar

    Active Implantable Medical Device Directive (AIMDD)

    Manufacturers of active implantable medical devices are only allowed to sell products on the EU market if they comply with the Active Implantable Medical Device Directive (90/385/EEC). DEKRA has been officially designated to review the compliance of products with the requirements of the AIMDD for access to the EU market.

    Transition from AIMDD to MDR
    The current AIMDD will be replaced by the MDR. This regulation came into force on May 25, 2017, and the transitional period will end in 2020. The regulation covers medical devices among which active implantable medical devices under a single text. The scope of the MDR has been extended to include additional devices.

    ISO 13485

    ISO 13485 helps you to meet the requirements that apply to your Quality Management System (QMS). Medical device manufacturers can use ISO 13485 to support the effectiveness of their processes. ISO 13485 is the internationally recognized standard for quality management in the medical device industry. It ensures an organization’s commitment to continuous improvement in terms of the design, safety and quality of medical devices, and it meets all industry requirements.

    MDSAP

    The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple countries. Led by various Regulatory Authorities (RA) worldwide, the initiative is aimed at enlarging efficiency and safety through increased consistency. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA. At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program. Sharing such knowledge is all part of our service.

    Read more

    Our services in detail:

    Medical Device Directive (MDD)

    Manufacturers of medical devices have a tremendous responsibility to keep end users safe. Therefore they need to comply with European regulations (93/42/EEC) to ensure that their innovative and continuously developed devices are safe and perform well. DEKRA is designated to review the compliance of products to the essential requirements of the MDD for access to the EU market.

    Transition from MDD to MDR
    The current MDD is being replaced by the Medical Device Regulations (MDR) which came into force on May 25, 2017. The transitional period will end in 2021. The scope of the MDR has been extended to include additional devices. 

    Medical Device Directive (MDR)

    This new Regulation brings a lot of changes. That is why it is important for all actors to be aware of the new requirements, and to prepare for and implement the new Regulation as soon as possible.

    The outlines  of the new Regulation:

    • Access for medical devices to the European market will become stricter and also requirements for manufacturers, importers and distributors and Notified Bodies will be expanded and reinforced:  Sharp demands on clinical evidence, especially for high-risk products, More stringent pre-market monitoring for high-risk products, Clear responsibilities for all economic participants
    • More transparency for patients
    • Better traceability of devices
    • Changes to classification rules meaning more devices are now in higher risk categories
    • Medical devices in a higher risk category must meet more stringent requirements in order to qualify for marketing authorization.

    Overall the intention of the new regulations is to ensure better protection of public health and patient safety. DEKRA is designated to review the compliance of products to the essential requirements of the MDR for access to the EU market.

    MDR: Frequently asked questions

    We rarely get as many questions about a topic as we do about the Medical Device Regulation (MDR). In our FAQ, you will find the answers to the questions we get time and again. Check it out frequently, because we will add more questions and answers to them from our experts.

    Open FAQ about MDR

    MDR Article 117

    The Medicines Directive 2001/83 has been significantly amended by the new Medical Device Regulation (MDR 2017/745). If you are a manufacturer of drug-device combination products regulated as medicinal products under Medicines Directive 2001/83 you need to be aware of Article 117 of the new regulation.

    Visit the Article 117 page

    In vitro Diagnostics Directive (IVDD)

    In vitro diagnostic devices are used to test tissue samples or bodily fluids. All in vitro diagnostic (IVD) devices sold in the European Union need to have a CE marking. The main objective of this is to make sure patients and users can rest assured that the products are safe for use. With the mark, the manufacturer shows that a device complies with all the relevant regulations. IVD devices are becoming more complex due to technological developments and other improvements. By conforming to the IVDD, the devices remain safe for use on patients even during times of continuous innovation. DEKRA has been officially designated to review the compliance of products to the essential requirements of the IVDD for access to the EU market.

    Transition from IVDD to IVDR
    The IVDR regulation was published on May 25, 2017, and the transitional period will run until 2022. The scope of the IVDR has been extended to include additional devices. 

    In-vitro-Diagnostic Medical Device Regulation (IVDR)

    The aim of this new regulation is to ensure better protection of public health and patient safety. Access for IVDs to the European market will be more stringent and the requirements for manufacturers, importers and distributors as well as notified bodies will be expanded and strengthened. Manufacturers of In-vitro-Diagnostics need to comply with European regulations to ensure that their innovative and continuously developed IVDs are safe and perform well. DEKRA is designated to review the conformity assessment to the European regulations for access to the EU market.

    DEKRA has two Notified Bodies for the EU In-vitro-Diagnostics Regulation (2017/746, IVDR):

    • DEKRA Certification GmbH (NB 0124) which was in October 2019 the first designated Notified Body in Europe for the Regulation and
    • DEKRA Certification B.V. (NB 0344) which received its designation in June 2021.

    DEKRA is active nearly everywhere in the world and the members of our in-vitro-diagnostic medical devices certification team have extensive expertise in a wide array of in-vitro-diagnostic devices.

    If you want to send us an application, please fill in our quote request form.

    You can also watch our webinar where we discuss the most important topics related to the new IVDR.

    Watch this webinar

    Active Implantable Medical Device Directive (AIMDD)

    Manufacturers of active implantable medical devices are only allowed to sell products on the EU market if they comply with the Active Implantable Medical Device Directive (90/385/EEC). DEKRA has been officially designated to review the compliance of products with the requirements of the AIMDD for access to the EU market.

    Transition from AIMDD to MDR
    The current AIMDD will be replaced by the MDR. This regulation came into force on May 25, 2017, and the transitional period will end in 2020. The regulation covers medical devices among which active implantable medical devices under a single text. The scope of the MDR has been extended to include additional devices.

    ISO 13485

    ISO 13485 helps you to meet the requirements that apply to your Quality Management System (QMS). Medical device manufacturers can use ISO 13485 to support the effectiveness of their processes. ISO 13485 is the internationally recognized standard for quality management in the medical device industry. It ensures an organization’s commitment to continuous improvement in terms of the design, safety and quality of medical devices, and it meets all industry requirements.

    MDSAP

    The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple countries. Led by various Regulatory Authorities (RA) worldwide, the initiative is aimed at enlarging efficiency and safety through increased consistency. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA. At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program. Sharing such knowledge is all part of our service.

    Read more

  • Customer case

    Inreda

    Inreda
    Read more about Inreda

  • Meet our experts

  • Tamara Garcia
    Contact person

    Tamara Garcia

    Medical Device Services
    Contact
  • Tim van den Berg
    Contact person

    Tim van den Berg

    Electrical Medical Devices
    Contact
  • Related services

    Wireless

    wireless
    Read more
    Related service

    Electrical

    electrical safety testing
    Read more
    Program

    Medical Device Single Audit Program

    MDSAP
    Read more


  • Upcoming events

    No events are planned at this time. Please check back later.


  • On demand webinars

    23 October 2017
    webinar Image

    MDR Status & Highlights

    In this status update we talk a.o. about:

    • Timelines of the transitional period
    • Impact on CE certificates
    • Validity MDD and AIMDD certificates
    • Transitional provisions

    Watch this webinar

    19 December 2017
    Image webinar

    MDR Clinical Evaluation Requirements

    DEKRA's experts address, amongst others:

    • Clinical evaluation
    • Post market surveillance and pm clinical follow-up
    • CE mark obtained through equivalence

    Watch this webinar

    January 23, 2018
    webinar image

    MDR Classification and Conformity Assessment Routes

    The third webinar in the MDR expert series focuses on the changes in Classification and Conformity Assessment Routes in the MDR compared to the Medical Device Directive (MDD).

    Watch this webinar