MDRC Consulting

MDRC
Verified

MDRC is a nonprofit, nonpartisan research organization founded in 1974, dedicated to improving the lives of people with low incomes by designing and evaluating programs and policies. They provide evidence-based solutions to complex social problems.

Founded in 1974, MDRC is a nonprofit, nonpartisan research organization committed to improving the lives of people with low incomes. They design promising new interventions, evaluate existing programs, and provide technical assistance to build better programs. MDRC develops evidence about solutions to some of the nation’s most difficult problems, exploring projects and a variety of products including publications, videos, podcast episodes, and resources for researchers and practitioners. Their work involves conducting rigorous studies of programs and policies that affect people with low incomes, actively disseminating lessons to policymakers and practitioners, and working directly with programs and agencies to help improve their effectiveness and efficiency. MDRC collaborates with public agencies, educational institutions, nonprofits, and other organizations dedicated to improving the lives of individuals, families, and communities. MDRC offers services such as conducting research and evaluations, creating and testing new interventions, improving programs and processes, and promoting the use of evidence in policymaking. They also design innovative methodologies and tools for evaluation, data analysis, and technical assistance, and produce public-use data files from their projects for other researchers. With a multidisciplinary staff of researchers, former educators, and program operators, MDRC works across various domains including education, criminal justice, housing, and job training. They are committed to creating an environment that fosters teamwork and mutual respect, ensuring no one is excluded or discriminated against. MDRC's mission is supported by a deep respect for the knowledge of on-the-ground program staff and individuals directly affected by the programs and policies they study.

About

**Who they are**
MDRC Consulting is a research organization dedicated to improving lives through evidence-based solutions. They offer specialized services to help medical device and IVD manufacturers navigate complex regulatory requirements.

**Expertise & scope**
* Ensuring compliance with EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
* Providing a designated Person Responsible for Regulatory Compliance (PRRC) to meet regulatory obligations.
* Supporting manufacturers located inside and outside the EU.
* Assisting with the responsibilities of the EU Authorized Representative concerning PRRC.
* Facilitating EUDAMED registration by providing the PRRC's name.
* Acting as the primary contact for EU competent authorities regarding regulatory compliance.

**Reputation / proof points**
* Founded in 1974, MDRC Consulting has a long history of providing research and evaluation services.

Additional information

MDRC Consulting clarifies that the PRRC role does not necessitate a new full-time employee. The function can be fulfilled by an existing staff member who meets the minimum qualifications, or by engaging an external service provider like MDRC Consulting. This approach offers flexibility for manufacturers, particularly smaller companies, in meeting the regulatory requirement for a PRRC. The PRRC's responsibilities are crucial for ensuring the conformity of devices, maintaining technical documentation, overseeing post-market surveillance, and fulfilling reporting obligations.

Key Highlights

  • MDR and IVDR require manufacturers to have a Person Responsible for Regulatory Compliance (PRRC) available. Source
    “Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation – IVDR (EU 2017/746) require companies to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal.”
  • The PRRC is a regulatory expert responsible for ensuring the company meets applicable EU medical device requirements. Source
    “PRRC is a regulatory expert whose responsibility is to ensure that the company is meeting applicable medical device requirements in the EU.”
  • PRRC qualifications require at least one year of professional experience in regulatory affairs or quality management systems related to medical devices. Source
    “At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.”
  • The PRRC's duties include ensuring conformity checks, maintaining technical documentation, and overseeing post-market surveillance. Source
    “the conformity of the devices is appropriately checked in accordance with the quality management system under which the devices are manufactured, before a device is released”

Certifications & Trust Signals

  • MDRC Consulting was founded in 1974. Source
    “MDRC is a nonprofit, nonpartisan research organization founded in 1974”

Buyer Snapshot

Best for
  • Medical device manufacturers needing EU PRRC support.
  • IVD manufacturers requiring regulatory compliance expertise.
  • Companies seeking external PRRC services.
How engagement typically works
  • External PRRC provision.
  • Consultative support for regulatory compliance.
Typical deliverables
  • Designated PRRC.
  • Support for MDR/IVDR compliance.
  • Assistance with technical documentation and post-market surveillance.
Good to know
  • Best when manufacturers require external expertise for PRRC functions or need to ensure compliance with EU MDR/IVDR.

Pricing

Model: Custom pricing
HQ: New York, US
Public email: info@mdrc-consulting.com
Phone: 212-684-0832
Languages: English, Greek
Timezones: Asia/Nicosia
Access: Verified
Claim status: Listed

Services & Capabilities

Find PRRC Services | EU MDR/IVDR Providers & Quotes

Jurisdictions: EU
Industries: Medical devices, IVD, SaMD, Manufacturing
Portfolio: 1-5
Onboarding time: 7–30 days
Pricing model: Custom pricing
Starting from: EUR 1,200
Included services: PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC: No
PRRC Qualification Summary: At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices (EU requirements). Alternatively, four years of professional experience in regulatory affairs or quality management systems relating to medical devices.

Additional prrc_service Details

Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup procedures for engaging their PRRC services.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Supports MDR
true
Supports IVDR
true
PRRC Qualification Summary
At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices (EU requirements). Alternatively, four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
Regulatory Experience
Minimum 1 year of experience in regulatory affairs or quality management systems for medical devices.
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
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