Our glossary for guidance - Letter R

Rules on work safety on construction sites.

Shortcut for Research Ethics Committee.

[Definition of term as per MDCG 2021-08 Acronyms and MDCG 2021-28 Acronyms]

‘Recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user.

[Definition under (EU) 2017/745 Article 2 No. 62 also corresponds to definition under (EU) 2017/746 Article 2 No. 65]

A recommendation can arise in connection with audits. Recommendations must be evaluated and, if necessary, measures must be taken and initiated, if this is feasible for the company. Recommendations are not to be seen as an unnecessary evil of the auditor, but as an indication for improvement of the management system.

This illustrative experiment (also known as "Red Beans") by Deming gives an example of a work step in which the employees have no influence on the result of their work and the achievement of the goal is unlikely. However, these very employees are rewarded or punished for this uncaused result.

‘Reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;

[Definition according to (EU) 2017/745 Article 2 No. 39]

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 and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4, also corresponds to definition under (EU) 2017/745 Annex VIII 2.3]

Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out.

[Definition according to (93/42/EEC) Annex IX No. 1.3]

‘Reusable surgical instrument’ means 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 and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.3]

Retrospect on what has been achieved and what has been learned from it.

The combination of the probability of occurrence of harm and the severity of that harm.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 16]

‘Risk’ means the combination of the probability of occurrence of harm and the severity of that harm.

[Definition under (EU) 2017/745 Article 2 No. 23 also corresponds to definition under (EU) 2017/746 Article 2 No. 16]

The robustness of an analytical procedure means the capacity of an analytical procedure to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
Source: ICH Q2(R1)– Validation of analytical procedures

[Definition according to MDCG 2022-2 No. 4]

Regierungspräsidium.

Rolled Throughput Yield = First passed Yield.