MDR Tests

MDR Tests

On 25 May 2017, the European Union adopted a new set of regulations replacing the Medical Device Directives (MDD) 93/42 / EEC and the Active Implantable Medical Devices Directive (AIMD) 90/385 / EEC. 

MDR Tests

It applies to all medical device manufacturers who want to market their devices in the European Union. The new Medical Device Directive (MDR) becomes applicable and enforceable until May 3 for a 2020-year transition period. 

After May 2020, all new devices and all devices with expired CE marking must comply with the new MDR. This means that CE devices marked under the old MDD or AIMDD may no longer be marketed or put into service unless they are re-shipped and do not fully comply with the new MDR. Until May 2025, the only medical devices permitted on the market in the European Union will be those that qualify for the new MDR.

Some of the key changes for medical device manufacturers include:

  • A wider scope of regulated medical devices;
  • More pre-market reviews for high risk devices
  • Stricter clinical evidence and documentation requirements
  • Strengthening post-market surveillance
  • No very old devices will be available under the new MDR

Some important MDR dates for medical device manufacturers:

1.May 2017 MDR released and 3-year transition started
2.May 2020 MDR made feasible and applicable

  • All new devices or devices with expired certificate
  • All Class I, self-certified devices and custom-made devices (except Class III implantable) must be MDR compliant
  • Class I reusable surgical instruments, Class III implantable custom-made devices, newly introduced MDR devices and devices classified as Class I self-certified products must be approved by the Notified Body
  • Combination products of a pharmaceutical and medical device that are considered medical products must comply with the General Safety and Performance Requirements and, where possible, be compatible with the participation of the notified body.
  • Clinical trials must comply with MDR
  • All post-market surveillance requirements of MDR apply

3.May 2022 Certificates issued pursuant to AIMDD Annex 4 and MDD Annex IV that have not expired yet will be invalid.
On May 4, 2024 , all other certificates issued within the scope of the directives in force and not yet expired will be invalid.
On May 5, 2025 Under MDD or AIMDD, CE marked devices may no longer be marketed or put into service in the European Union; only MDR CE certified devices are allowed.

How do these dates affect me?

Depending on the type of device you want to market and the type and date of certificate they currently have, it will determine the urgency of getting your device certified under the new MDR.

As many companies will rush to get certified under the new MDR, you'll want to get your device's MDR certification as soon as possible if:

  • The device is currently Class 1 self-certified, but will be certified by the Notified Body under the MDR
  • The product is not currently considered a medical device but will be covered by the MDR
  • Clinical evidence is sufficient for your device
  • The device is CE marked now and no design changes are planned for the next few years
  • The device you are promoting is new

You may have a little more time if:

  • You are planning to introduce new devices between 2020 and 2022
  • You currently have sufficient clinical evidence
  • You follow appendix IV of MDD or appendix 4 of AIMDD
  • Will not change Notified Bodies

You may have more time or need more time to certify your device if:

  • Have a CE mark now and don't expect any design changes in the next few years
  • If you don't expect the classification of your device to change
  • If you need more time to collect clinical data for existing CE marked devices

However, not all companies or products will fall into one of these categories. Most should take a mixed approach to certify their devices, depending on the type and variety of devices they currently have, new products, the quantity and quality of available clinical evidence, and internal resources available for certification of devices.

EUROLAB How can it help you comply with the new MDR?

If you need help understanding the requirements or would like someone to help conduct a gap analysis for current compliance as you plan your MDR migration strategy, EUROLAB, has a team of expert consultants and a process to help manufacturers bring in their devices. The details of the evaluation process will depend on the number and range of devices being evaluated and their clinical use history.

Understanding these new regulations and preparing to meet them is no small undertaking. Because EUROLABThe expert consultants at are ready to help you understand your testing needs and get your products certified and safe to the patients who need them.

EUROLABcan help you create a clear strategy to meet this new MDR.

EUROLAB, with its highly expert team and internationally accredited laboratories, MDR Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.