Medical Device Services

medical device services

Ensuring safe medical devices for global markets

The safety and quality of medical devices is becoming increasingly important as the healthcare industry prepares to enter the next decade. Firstly, consumers are demanding the highest safety standards from suppliers of products and services in the healthcare sector. Secondly, international rules and regulations for medical device manufacturers are becoming increasingly complex and stringent as devices become more innovative, but also more prone to privacy issues, security threats, and health risks.

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. 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. At DEKRA, 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 diagnostic devices.

Why DEKRA?

  • 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 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 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.

Selected accreditations

  • MDSAP Recognized
  • AIMDD
  • MDD
  • IVDD
  • EN ISO 13485 (RvA)
  • ISO 13485: 2016
  • ISO 13485 CMDCAS (SCC)
  • Australia - TGA
  • Brasil - INMETRO
  • Canada - CMDR
  • Japan - J-PMDact (JPAL)
  • Taiwan - TCP

Our services in detail

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 2020. The scope of the MDR has been extended to include additional devices. At DEKRA, we have hosted webinars about this topic to inform our customers about the transition to the MDR.

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. At DEKRA, we have hosted webinars about this topic to inform customers about the transition to the IVDR.

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 are active implantable medical devices under a single text. The scope of the MDR has been extended to include additional devices.

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.

Revision of ISO 13485:2016

The publication of ISO 13485:2016 on March 1, 2016, marked the beginning of a three-year transitional period. This transition will impact both manufacturers and certification bodies. The updated standard is based on ISO 9001:2008 instead of ISO 9001:2000. This makes it more flexible in some aspects (e.g. the exclusion of requirements from sections 6, 7 and 8). However, it becomes stricter in other respects; for example, the QMS must now also comply with ISO 13485 as well as all the applicable regulatory requirements.

The most notable deadlines are:

  • As of March 1, 2018, no issuance of new or renewed ISO 13485:2003/EN ISO 13485:2012 certificates
  • As of March 1, 2018, application for certification to ISO 13485:2003/EN ISO 13485:2012 will no longer be possible
  • As of March 1, 2019, end of validity of existing ISO 13485:2003/EN ISO 13485:2012 certificates. Only ISO 13485:2016 certificates will be valid as of March 1, 2019.

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 enhancing efficiency and safety through increased consistency. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA.

The impact is the largest in Canada, as Health Canada intends to replace the current CMDCAS certification with MDSAP. 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.

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