The coming into effect of the Medical Devices Regulation (MDR) has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir). This new sub-class has left several manufacturers with the difficult decision to reclassify their devices according to the new rules of the MDR risk classification system.
What is a reusable surgical instrument?
As per MDR, a reusable surgical instrument is an instrument:
- Intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures;
- Without a connection to an active device (whose operation depends on a source of energy other than human effort or gravity);
- Intended by the manufacturer to be reused after cleaning, disinfection, and sterilisation.
What is an example of a Class Ir?
Examples of devices classified as reusable surgical instrument under classification rule 6 of the MDR are:
- Scalpels and scalpel handles
- Reamers
- Drill bits
- Saws, that are not intended for connection to an active device
- Retractors forceps, excavators and chisels
- Sternum retractors for transient use
- Staplers (outside the heart, central circulatory or central nervous system
- Dental Osteotomes
Why is a Class Ir a legacy device?
As per Article 52(7) of the MDR, for the conformity assessment of class I reusable surgical instruments (Class Ir), the involvement of a notified body is necessary. This sets these devices under the definition of a legacy device under Article 120(3) MDR, which covers:
- Devices that did not need the involvement of a notified body under the previous Medical Devices Directive and have a Declaration of Conformity drawn up prior to 26 May 2021; AND
- Need the involvement of a notified body under the MDR
Provided that these devices comply with the requirements of the extended transitional period, they can be placed on the market or put into service until 31 December 2028.
Obelis can assist you with the classification of your device and verify their compliance with MDR requirements. Do not hesitate to contact us!
Pablo de Mingo Monge
Publications department
18.08.2023
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