RAC Exam Updates - Effective Starting July 11, 2022

MDR & MDD

  • MDR are EU-based regulations.
  • MDR are new regulations that went into effect before Dec 31, 2021; they supersede old regulations (MDD).
  • MDR questions will be on the updated RAC-Devices exam.

IVDR & IVDD

  • IVDD are EU-based regulations.
  • IVDR will replace the old regulations (IVDD) but not until May 2022.
  • IVDD was still in effect as of Dec 31, 2021; IVDR items will remain on the exams until next year.

FAQS

To what extent will MDR be covered in the EU portion of the RAC-Devices exam?
Roughly 17% of the RAC-Devices exam relates to MDR either directly or indirectly. 

Since the application of some key aspects of MDR is still being established, will the test questions covering MDR be largely recalled?
Out of roughly 17% of the exam, half are applications. The other half are recall and analysis. 

Switzerland has opted out of moving to MDR even though it’s part of the EU. What impact does this have on the exam items?
Neither the RAC-Drugs nor RAC-Devices exams (2022 exam forms) have items specific to Switzerland. 

To what extent will IVDR be covered in the EU portion of the RAC-Device exam?
IVDR comprises 0-2% of the content on the 2022 exam forms

What percent of the exam will cover the UK or Britain specifically?
0-1%; UK is no longer part of the EU because it left the EU due to Brexit. 

Does MDD or MDR apply to the UK?
Given the lack of clarity at the time of exam writing, candidates do not need to know this for purposes of the 2022 exams.

What percent of the exam will be integrative questions v. recall v. application?
The rough breakdown for both exams on the 2022 forms is as follows:
RAC-Drugs:
  • Recall: 35%
  • Application: 50%
  • Analysis: 15%
RAC-Devices:
  • Recall: 35%
  • Application: 45%
  • Analysis: 25%