MDRC Consulting
MDRC
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 nonprofit, nonpartisan research organization founded in 1974, dedicated to improving lives through evidence-based solutions. They specialize in providing regulatory compliance expertise for medical device and IVD manufacturers.
**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 ensure manufacturers meet applicable EU medical device requirements.
* Overseeing critical regulatory functions including technical documentation, quality systems, post-market surveillance, and reporting obligations.
* Supporting manufacturers located both within and outside the EU, including those requiring an Authorized Representative.
**Reputation / proof points**
* Founded in 1974.
MDRC Consulting is a nonprofit, nonpartisan research organization founded in 1974, dedicated to improving lives through evidence-based solutions. They specialize in providing regulatory compliance expertise for medical device and IVD manufacturers.
**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 ensure manufacturers meet applicable EU medical device requirements.
* Overseeing critical regulatory functions including technical documentation, quality systems, post-market surveillance, and reporting obligations.
* Supporting manufacturers located both within and outside the EU, including those requiring an Authorized Representative.
**Reputation / proof points**
* Founded in 1974.
Additional information
Manufacturers must have a PRRC available to ensure regulatory compliance for devices on the EU market. This role is crucial for EUDAMED registration and is a primary point of contact for EU authorities. The PRRC function can be fulfilled by an internal employee or an external service provider, offering flexibility for companies of all sizes. Ensuring the PRRC has the requisite expertise, as detailed in Article 15 of the MDR/IVDR and MDCG 2019-7 guidance, is paramount for successful regulatory adherence.
Key Highlights
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MDR and IVDR require manufacturers to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal.
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.”
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PRRC expertise includes ensuring conformity checks, technical documentation upkeep, post-market surveillance, and reporting obligations.
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”
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The PRRC is a key contact for EU authorities and is essential for EUDAMED registration.
Source
“Уклониться от этого нового европейского требования не удастся, ведь наличие PRRC необходимо для регистрации в системе EUDAMED.”
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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.”
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Alternatively, four years of professional experience in regulatory affairs or quality management systems relating to medical devices is also accepted.
Source
“four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.”
Certifications & Trust Signals
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Founded in 1974, MDRC Consulting has a long history of providing research and solutions.
Source
“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.”
Buyer Snapshot
Best for
- EU MDR/IVDR compliance for medical device manufacturers
- Companies needing external PRRC expertise
How engagement typically works
- Outsourced PRRC function
- Consultative support for regulatory compliance
Typical deliverables
- Designated PRRC
- Ensured compliance with MDR/IVDR Article 15
- Support for technical documentation and quality systems
- Post-market surveillance and reporting oversight
Good to know
- Best when requiring specialized regulatory knowledge for EU market access.
Pricing
Model:
Custom pricing
HQ:
New York, US
Languages:
English, Greek
Timezones:
Asia/Nicosia
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get 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
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 process involves appointing a PRRC, which can be an internal employee or an external service. The PRRC's name is communicated to EU authorities via EUDAMED registration. Manufacturers need to ensure their PRRC meets the specified qualifications and fulfills key responsibilities.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Requires at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices, or alternatively, four years of such experience.
Regulatory Experience
Experience in regulatory affairs and quality management systems related to medical devices, specifically for EU MDR and IVDR compliance.
Device Classes Supported
Class I, IIa, IIb, III
