Pure Clinical
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About
**Who they are**
Pure Clinical is a research and development center established by experts from notified bodies, competent authorities, industry, and consulting. They focus on providing comprehensive support for manufacturers, importers, and distributors of medical devices.
**Expertise & scope**
* Expertise in design, clinical research, certification, and post-market surveillance to accelerate innovation from concept to patient.
* Guidance on MDR and IVDR realities, advising before issues arise.
* Support for manufacturers and EU authorized representatives in appointing and managing the Person Responsible for Regulatory Compliance (PRRC).
* Services include Clinical Trials, Designing Clinical Trials, IVD Performance Studies, IVD Feasibility Assessment, Medical Device Site Selection, Medical Device Trial Monitoring, Clinical Data Management, Statistical Analysis, and Medical Writing.
* Focus on EU market access and certification.
**Reputation / proof points**
* Founded through the merger of MDR Regulator and a clinical research team.
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
Pure Clinical is a research and development center established by experts from notified bodies, competent authorities, industry, and consulting. They focus on providing comprehensive support for manufacturers, importers, and distributors of medical devices.
**Expertise & scope**
* Expertise in design, clinical research, certification, and post-market surveillance to accelerate innovation from concept to patient.
* Guidance on MDR and IVDR realities, advising before issues arise.
* Support for manufacturers and EU authorized representatives in appointing and managing the Person Responsible for Regulatory Compliance (PRRC).
* Services include Clinical Trials, Designing Clinical Trials, IVD Performance Studies, IVD Feasibility Assessment, Medical Device Site Selection, Medical Device Trial Monitoring, Clinical Data Management, Statistical Analysis, and Medical Writing.
* Focus on EU market access and certification.
**Reputation / proof points**
* Founded through the merger of MDR Regulator and a clinical research team.
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
Additional information
Pure Clinical emphasizes a partnership approach, working collaboratively with companies to navigate complex regulatory landscapes. They understand that a product's success relies on clinical data, precise regulatory interpretation, and efficient certification strategies. Their team comprises professionals with direct experience from notified bodies and quality system implementation, offering a complete view of the product lifecycle. This allows them to streamline processes, mitigate risks, and aim for first-time approval of documentation. They are positioned to help clients anticipate regulatory changes and design strategies for faster market entry without compromising compliance.
Key Highlights
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Pure Clinical was founded through the merger of MDR Regulator and a clinical research team.
Source
“Pure Clinical was founded through the merger of MDR Regulator – an organization shaping medical device compliance across Europe – and a research team conducting clinical and preclinical projects.”
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They have supported over 500 projects and achieved 230 certifications.
Source
“Our partnership is a measurable advantage: over 500 projects, 230 certifications, and clients from 37 markets.”
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Their team includes former notified body experts and quality system implementers.
Source
“Our team is made up of professionals who once assessed technical documentation within notified bodies, led clinical investigations, and implemented quality systems for global manufacturers.”
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They offer direct access to experts with proven MedTech experience for regulatory support.
Source
“Direct access to experts with proven MedTech experience.”
Certifications & Trust Signals
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Pure Clinical guides products from concept to EU market access.
Source
“A trusted partner guiding your product from concept to EU market access.”
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They possess knowledge of MDR and IVDR realities from both institutional and operational perspectives.
Source
“We know MDR and IVDR realities from both sides – institutional and operational – which allows us to advise before a problem arises.”
Buyer Snapshot
Best for
- Manufacturers and importers of medical devices and IVDs seeking PRRC support.
- Companies needing guidance on EU MDR and IVDR compliance.
- Organizations looking to accelerate product certification and market entry.
How engagement typically works
- Collaborative partnership model.
- Direct access to experienced MedTech experts.
- Tailored collaboration models.
Typical deliverables
- PRRC appointment and ongoing compliance support.
- Technical documentation review and preparation.
- Post-market surveillance strategy and execution.
- Clinical trial design and management.
- EU certification and registration support.
Good to know
- Best when seeking expert guidance on complex EU medical device regulations.
- Best when aiming for efficient and compliant market access.
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Dublin
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Custom
Device Classes Supported:
Class III, IVD
PRRC Qualification Summary:
The PRRC must meet the criteria set out in MDR and IVDR: Familiarity with ISO 14155 (clinical investigation) and ISO 14971 (risk management), clinical evaluation, and market surveillance processes is essential. In practice, documentation proving PRRC qualifications should be part of the QMS and include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7. The PRRC is also responsible for correct EUDAMED data entries related to compliance and post-market surveillance under Articles 29 and 31 of MDR and IVDR.
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
Requires appointment of a PRRC, with documentation including CVs, role descriptions, and contracts as part of the QMS. Pure Clinical supports manufacturers with PRRC compliance.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Familiarity with ISO 14971 (risk management), clinical evaluation, and market surveillance processes. Documentation proving qualifications should be part of the QMS and include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7.
Regulatory Experience
Extensive experience derived from assessing hundreds of products, working within notified bodies, leading clinical investigations, and implementing quality systems for global manufacturers.
