MEDICAL DEVICE REGULATION

Jun 10, 2024

Authorisation of NON-STERILE implants remains in place, traceability is also given here.

Non-sterile packaged implants remain authorised, contrary to the widespread assumption that exact traceability is only guaranteed via sterile packaged implants. According to Article 18
of the MDR, this assumption is excluded. The MDR Regulation EU 2023/607 regulates the transitional provisions, the repeal and entry into force as well as the date of application.

In addition, the MDR does not require individual packaging of small surgical materials, meaning that the non-sterile packaged surgical kits previously used may continue to be offered and used. Here you will find the statements of the DGOU and can view our written agreement with the Federal Ministry of Health.

What you need to know

The advantages and disadvantages of non-sterile and sterile packaged implants

Non-sterile packaged implants offer numerous advantages. They are more cost-efficient to manufacture, store and use. In contrast to sterile-packed implants, which have to undergo a complex and energy-intensive sterilisation process, non-sterile-packed implants can be used more flexibly. This flexibility makes it possible to choose the sterilisation method according to requirements and circumstances.

ADVANTAGES AND DISADVANTAGES

Make the right decision

Non-sterile packaged implants offer numerous advantages. They are more cost-efficient to manufacture, store and use. In contrast to sterile-packed implants, which have to undergo a complex and energy-intensive sterilisation process, non-sterile-packed implants can be used more flexibly. This flexibility makes it possible to choose the sterilisation method according to requirements and circumstances.

The production of sterile-packed implants requires considerably more energy, produces more packaging material and leads to a higher amount of waste. This increased consumption of resources has not only financial but also ecological disadvantages. Non-sterile packaged surgical kits are therefore not only an economical but also a more environmentally friendly alternative.

Doctors and purchasers should consider these advantages in order to make an informed decision that takes both the financial and ecological aspects into account.

COMMITMENT TO<br />
SUSTAINABILITY
WE STAND FOR