Medical Device Classification Class Ir

Class Ir Reusable Surgical Instruments

EU MDR 2017/745 introduce new requirements for Reusable Surgical Instruments. All reusable surgical instruments falls under class 1r and are subject to conformity assessment by Notified Bodies.

Reusable Surgical Instruments are defined as “instruments intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out

MDR Class Ir CE Marking as per Article 20.1, 20.3, 20.4 and 20.5 and Article 52 (7c) can be achieved in the following methods:

  • Examination and testing of each product or homogenous batch of products (Annex IV)
  • Audit of the production quality assurance system as per Annex VIII, Chapter 1, 2.3(Annex V) and EN ISO 13485:2016 (excluding Design)
  • Audit of final inspection and testing (Annex VI) EN ISO 13485:2016 (excluding Design & Manufacture)
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2016

Details about Annex can be obtained from Medical Device Regulation-MDR.

In short Class Ir Reusable manufactures has to..

  • Upgrade existing Technical File in line with MDR requirments with more details related to reuse in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
  • Clinical Evaluation and Risk Assessment documentation.
  • Issue a Declaration of Conformity.
  • EN ISO 13485:2016 Implementation.

We support class Ir Medical Device manufactures with the following Services

(a) Guidance & Technical File

(b) Identify test requirments and review the external reports.

(c) Arrange Notified Body and Coordinate with them till issue of CE Certificate.

(d) Arrange EU Representative from Europe

(e) Arrange Free Sale Certificate from Europe.

More details about Class 1r CE Certification Process click here .

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