CE Certification AIMD+MDD/MDR

Fulfil Compliance Requirements of the Current Medical Devices Directives and the New Medical Devices Regulation

Medical device manufacturers seeking the commercialization of their products in the European Economic Area (EEA), need the CE certification to show compliance with European regulations (Active Medical Device Directive 90/385/EEC and Medical Devices Directive 93/42/EEC until repeal and Medical Devices Regulation EU 2017/745) to ensure that their developed devices and the corresponding updates are safe for the patients and users and do not harm the environment.

The benefits of CE Certification AIMD+MDD/MDR

  • Certification to the requirements of the current Directives (AIMD or MDD) until repeal for eligible products

  • Smooth transition from certification under the Directives to our established program under the Regulation

  • Certification according to the requirements of the new Medical Device Regulation and existing products in parallel with MDD DirectiveIndependent confirmation that the product meets the applicable essential requirements or general safety and performance requirements

  • Proof of compliance with all the relevant EU requirements

  • Better access to markets adopting and/or recognizing the EU regulations

CE Certification MDD/MDR

About CE Certification AIMD+MDD/MDR

Ensuring the safety and quality of your medical devices starts with DEKRA. We are one of the largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices. In order for medical device manufacturers to demonstrate the safety and quality of medical devices and related services, our customers need to comply with the applicable European legislation (AIMD, MDD or MDR) which provide a framework to demonstrate that requirements for safety and performance have been met.

The Active Medical Device Directive 90/385/EEC and Medical Devices Directive (MDD) 93/42/EEC are being replaced by the Medical Device Regulation (MDR) (EU) 2017/745, which came into force on May 26, 2017. The scope of the MDR has been extended to include additional devices and more strict requirements to ensure better protection of public health and patient safety.Once notified bodies, like DEKRA, have been designated to offer conformity assessment under the MDR, products can enter the process. DEKRA is already working with clients towards CE-marking their products under the MDR.

The directives were due for repeal on May 26, 2020 followed by a transition period that ends on May 26, 2024. From the date of repeal conformity assessment for new or changed devices under the AIMD or MDD is no longer possible.

In response to the COVID-19 pandemic, the date of repeal of the AIMD and MDD has been delayed by 1 year; without affecting other dates. This means that products can still undergo conformity assessment under the AIMD and MDD.

DEKRA’s experts check and assess the full compliance of our customers’ products to the applicable essential requirements of the AIMD or MDD and now the general safety and performance requirements of MDR, allowing our customers to affix the CE Marking to their products for access to the EU market.

In addition, DEKRA has a Notified Body for CE-marking PPE (Personal Protective Equipment) according to Regulation 2016/425 providing a complete service to manufactures whose product range includes medical devices and PPE.

It is essential for medical device manufacturers to have the right assessment relating to all the latest requirements for them to avoid delays in marketing their products. The assessment has to take into account the following new aspects of medical devices:

  • New classification of medical devices in addition to the new groups of devices covered by the new regulation.
  • A different conformity assessment approach according to the risks over the safety of patients and users. With the MDR, there is a change in categories, including requiring notified bodies to perform conformity assessment for devices that could be “self-declared” under the MDD.
  • More stringent pre-market monitoring for high-risk products.
  • Demands on clinical evidence, especially for high-risk products.
  • Assessment on transparency and traceability of devices.
  • DEKRA has the capacity to perform conformity assessment for all medical devices. Our clinical and technical experts will be able to provide:
  • Global coverage of on-site auditing of the development and production facilities (including critical supplier audits, as required).
  • Timely Technical Documentation reviews under the Directives and Regulation.