MDR Medical Device Tests

MDR Medical Device Tests

In 2007, the Ministry of Health published the Regulation on Implantable Active Medical Devices in parallel with the efforts of adapting the European Union directives to the legal regulations of our country.

This regulation,

  • To determine the essential properties of the implantable active medical devices used for human health
  • The design, manufacture and delivery of these devices to consumers
  • Use by consumers
  • To ensure that patients, practitioners, users and third parties are not exposed to health and safety hazards during use, and
  • To regulate the principles for the inspection of these devices.

This regulation is based on the following European Union directives on implantable medical devices:

  • Directive 90 / 385 / EEC on implantable active medical devices
  • Directive 93 / 42 / EEC on medical devices amending this Directive, and
  • Directive on CE marking 93 / 68 / EEC which also amends the same directive

In line with the studies on the development of medical devices with the described features, the Medical Device Regulation (2017 / 745) was issued by the European Union in the previous year. This new regulation actually combines the following two:

  • MDD, Medical Devices Directive (93 / 42 / EEC)
  • AIMDD, Active Implantable Medical Device Directive (90 / 385 / EEC)

The main reasons for switching to the new regulation are:

  • Supervision of notified bodies
  • Conformity assessment activities
  • Clinical trials and clinical evaluations
  • Be alert to a danger
  • Market surveillance
  • Transparency and traceability

A transition schedule has also been set for the new application. According to this,

  • 26 May, 2020 / 93 / 42 / EEC and 90 / 385 / EEC directives will continue certification studies until May,
  • After this date, devices can be introduced to the market under the MDR directive.

Within this scope, the validity date of the documents issued in accordance with the requirements of Annex IV of Medical Devices Directive 93 / 42 / EEC shall be 26 May 2022. The last validity date of all documents issued on the basis of directives 93 / 42 / EEC and 90 / 385 / EEC is determined as May 2024.

In the meantime, 2025 is the last date on the market for the devices offered to the market in accordance with the relevant directive principles.

The structural differences between the MDD directives in force and the recently published MDR directive are very large and contain considerable detail. At least the previous directive contains the 60 page, the 23 clause and the 12 supplement, while the last directive contains the 175 page, the 123 clause and the 16 supplement.

Medical devices are developing very rapidly in parallel with the developing technologies. More sophisticated and creative products are offered to the market every day. The current legal regulations are inadequate in a short time against the technical and scientific developments in the health sector. Different medical device systems are used in different countries and this causes manufacturers to have difficulties. On the other hand, the lack of a common registration system and the difficulty of oversight and supervision due to free border crossings are other problems in this area.

The new implementation initiated by the medical device regulation (MDR) numbered 2017 / 745 brings significant changes, including certification bodies, after-sales surveillance, clinical evaluation, transparency, product information and audits.

In particular, this new regulation includes certain products that are not covered by the previous directives 90 / 385 / EEC and 93 / 42 / EEC. Implantable products or products such as non-corrective contact lenses, aesthetic implants and dermal fillers that are similar to medical devices in terms of risk profile and characteristics, but which do not have a medical purpose are also included in MDR.

Our company also provides MDR medical device testing services within the scope of other testing services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

MDR medical device testing services provided within the scope of other testing services are only one of the services provided by our organization in this respect. Many other testing services are also available.