RAPS puts PRRCs, manufacturers and authorized representatives in the same virtual room for four hours on — working through the Article 15 compliance challenges the role actually presents under the EU's MDR and IVDR, not just the text of the regulation.

Dates and format

  • Date: 1 December 2026, 9 a.m.–1 p.m. ET
  • Format: virtual, interactive four-hour workshop
  • Organizer: Regulatory Affairs Professionals Society (RAPS)
  • Pricing: early bird $315 member / $370 non-member through 1 November 2026; $370 / $430 regular
  • Credit: 4 RAC, 4 RCC

What it covers

The workshop teaches how the Person Responsible for Regulatory Compliance (PRRC) role functions in practice — at organizations small and large, with the role held internally or outsourced, at a manufacturer or an authorized representative, and across medical devices or IVDs. Expert presenters lead scenario-based discussion on Article 15 and connected parts of the MDR/IVDR, including the potential impact of amendments the European Commission proposed in December 2025.

Who should attend

Current and prospective PRRCs, plus the regulatory and quality leads who support them, at any organization placing devices or IVDs on the EU market. Comparing the broader MDR landscape first? RAPS's EU Medical Device Regulation 2017/745 workshop runs in November, and TOPRA's Annual Symposium covers EU regulatory affairs more broadly the following month.

Frequently asked questions

When is the RAPS PRRC Perspectives workshop?

1 December 2026, 9 a.m.–1 p.m. ET, held live and online. RAPS's own event page states this four-hour window; it was last confirmed on 22 September 2026.

How much does it cost?

Early bird pricing through 1 November 2026 is $315 for RAPS members and $370 for non-members. Regular pricing from 2 November through the workshop date is $370 (member) and $430 (non-member). Confirm current pricing on RAPS's own registration page before enrolling.

Does the workshop carry continuing education credit?

Yes — RAPS lists 4 RAC and 4 RCC continuing education credits for completing the workshop.

What does the workshop cover?

The role of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 and connected parts of the EU MDR and IVDR, worked through interactive scenarios, plus the potential impact of amendments to the MDR/IVDR the European Commission proposed in December 2025.

Who should attend?

PRRCs and prospective PRRCs at manufacturers and authorized representatives of any size, whether the role is filled internally or outsourced, and whether the products are medical devices or IVDs.

Sources & further reading

  1. RAPS. Workshop: PRRC Perspectives — Tackling Compliance Challenges Under MDR/IVDR. raps.org

Event details are published by the organizer and can change. Confirm dates, pricing and credit eligibility with RAPS before enrolling. Verified via WebSearch corroboration (direct organizer-page fetch was blocked this session) — last checked 22 September 2026.