North Miami, FL – December 2025 – MDR Consultants, a leading authority in EU MDR training, today announced the updated EU MDR 101 Course, an immersive online program designed to equip professionals with the critical regulatory knowledge needed to understand and interpret the EU Medical Device Regulation (EU MDR 2017/745). The course, last updated in August 2025, reflects the latest developments in regulatory timelines, transitional provisions, and compliance expectations. (EUMDR+1)

As the EU MDR continues to shape how medical devices are brought to market and monitored post-market, regulatory professionals — including Medical Device Internal Audit Consultants, QMS auditors, and those involved in EU MDR consulting — need a firm grasp of both the legal framework and practical interpretation of the regulation. The course addresses this need by offering a certification of comprehension, validating participants’ ability to interpret, analyze, and apply complex regulatory content.

Course Highlights — From Fundamentals to Advanced Interpretation

The EU MDR 101 Course guides learners through every key aspect of the regulation:

• Legal Framework & Regulatory Scope: Examine the history, application timelines, and scope of EU MDR, including transitional extensions and regulatory context. Learn from the European Commission’s official overview of medical device regulations.
• Quality Management System (QMS) Requirements & Audits: Understand compliance expectations and how to assess QMS effectiveness — essential skills for regulatory professionals.
• Risk Classification & Conformity Assessment Routes: Decode device classification and learn how regulatory pathways differ by risk class.
• General Safety & Technical Documentation: Gain expertise in analyzing and interpreting documentation required under EU MDR.
• Post-Market Surveillance (PMS) & Vigilance: Understand ongoing compliance requirements and the impact of regulatory changes.
• Gap Analysis Between MDD and MDR: Learn to perform gap analyses to identify compliance gaps and support effective regulatory strategy.

Certification That Accelerates Professional Growth

“This course was developed to move professionals beyond awareness to true expertise in EU MDR interpretation,” said Isabel Osorio, President of MDR Consultants. “With the August 2025 update, participants gain actionable knowledge they can apply immediately in their roles, whether performing QMS audits, conducting gap analyses, or advising on EU MDR compliance strategy.”

Participants completing the EU MDR 101 Course earn a certification of comprehension, a credential that demonstrates regulatory proficiency and sets professionals apart in EU MDR consulting, compliance leadership, and quality management roles.

About MDR Consultants
MDR Consultants is a trusted provider of EU MDR training and regulatory consulting services. Specializing in EU MDR, ISO 13485, and MDSAP audits, the firm delivers expert-led online courses and practical guidance to help medical device professionals build regulatory confidence and advance their careers.

Media Contact:
MDR Consultants
12410 Griffing Blvd., North Miami, Florida, 33161
Phone: (786) 306-0227
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