Exam Updates

RAC Exam Updates - Effective Starting with the Spring 2026 Exam Window

RAC Exam Changes:

The number of questions on the exam will increase from 100 to 120
The amount of time given to complete the exam will increase from 2 hours to 2.5 hours
Exam Content Outline changes
- Topics have moved to be more streamlined.
- Domain names and weights have changed. See comparison charts below.

2018 RAC-Devices – Current Version

Domain	Approximate Weighting
Strategic Planning	29%
Pre-marketing	25%
Post-marketing	38%
Interfacing	8%

2026 RAC-Devices – Future Version

Domain	Approximate Weighting
Strategic Planning	27%
Design and Development	27%
Process for Licensing, Registration, and Renewals	23%
Post-Market Activities	23%

2018 RAC-Drugs – Current Version

Domain	Approximate Weighting
Strategic Planning	24%
Pre-marketing	37%
Post-marketing	28%
Interfacing	11%

2026 RAC-Drugs – Future Version

Domain	Approximate Weighting
Regulatory Intelligence and Research	27%
Submissions	27%
Collaboration	13%
Strategy	22%
Project Management	11%

The following exam items will NOT change:

Exam format remains multiple-choice
Types of questions
Exam difficulty

Use the following updated resources to prepare for your exam:

Still have questions? Read through all the exam change FAQs:

Exam change FAQs

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 RAC-Devices exam (updated as of July 2022).

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; IVDD items will remain on the exams through Spring 2023.

FAQS

To what extent will MDR be covered in the EU (European Union) 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 recall questions?
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 is part of the EU. What impact does this have on the exam items?
Neither the RAC-Drugs nor RAC-Devices exams have items specific to Switzerland.

To what extent will IVDR be covered in the EU portion of the RAC-Device exam?
IVDR comprises 0-3% of the content.

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?
Candidates do not need to know this for the exams.

What percent of the exam will be integrative questions v. recall v. application?
The rough breakdown is as follows:

RAC-Drugs:

Recall: 35%
Application: 50%
Analysis: 15%

RAC-Devices:

Recall: 35%
Application: 45%
Analysis: 20%