EU MDR
& IVDR

Leaders in European Device Compliance

Why MDR & IVDR Are Hard

The Bar Moved. The Evidence Didn't Move With It.

MDR and IVDR raised the clinical and performance evidence bar for every device on the European market, reclassified thousands of products upward, and forced them through a notified body system with limited capacity and long queues. Devices that sold in Europe for years now need clinical evaluation, technical documentation, and post-market systems they were never built with. We help manufacturers classify correctly, build the evidence and documentation notified bodies actually accept, and reach CE marking without losing the market during transition.

Facing an MDR or IVDR deadline with a notified body queue ahead of you? Let's build the plan.

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Capabilities

Classification to CE Mark. Every Step, One Team.

CE marking under MDR and IVDR is a chain of dependencies, where a weak clinical evaluation or an unready technical file stalls the whole certification. We cover the full route to market and the systems that keep the mark valid afterward.

Classification & CE Pathway

Device and IVD classification, conformity assessment route, and the Annex pathway that fits your product and timeline.
Technical Documentation & GSPR

Annex II and III technical files and the General Safety and Performance Requirements evidence notified bodies expect.
Clinical & Performance Evaluation

Clinical Evaluation Reports (CER) for devices and Performance Evaluation Reports (PER) for IVDs, aligned to MDCG guidance.
Notified Body Strategy

Notified body selection, application readiness, and deficiency responses that keep your review moving toward certification.
Post-Market Surveillance

PMS and PMCF/PMPF plans, PSURs, and vigilance systems that satisfy the continuous obligations after the mark.
QMS, UDI & EUDAMED

ISO 13485 quality systems, UDI assignment, and EUDAMED actor and device registration for market entry.
Classification & CE Marking Pathway

Classification Decides Your Evidence, Your Cost, and Your Timeline.

Under MDR a device is Class I, IIa, IIb, or III; under IVDR an assay is Class A, B, C, or D. That class sets your conformity assessment route, whether a notified body is even involved, and how much clinical or performance evidence you owe. MDR and IVDR both pushed products up the risk ladder, so many self-certified devices now need full notified body review. We confirm the correct classification, choose the Annex route that fits your product and deadline, and map exactly what certification will require before you commit resources to it.

What We Assess

  • MDR classification (Class I, IIa, IIb, III) and rule application
  • IVDR classification (Class A, B, C, D) under the rules-based system
  • Conformity assessment route and Annex selection
  • Qualification as a medical device, IVD, or borderline product
  • Up-classification impact for legacy and self-certified devices
  • Intended purpose definition and its downstream effect
  • Gap and readiness assessment against the chosen route
Technical Documentation & GSPR

The Technical File Is What the Notified Body Actually Reviews.

MDR Annex II and III and their IVDR equivalents define the technical documentation every device needs, and the General Safety and Performance Requirements are the checklist your evidence has to answer point by point. Incomplete files are the most common reason certification stalls. We author and structure the full technical documentation, build the GSPR conformity matrix with linked evidence, and pressure-test it against the deficiencies notified bodies raise most often.

Included Capabilities

  • Annex II and III technical documentation authoring
  • General Safety and Performance Requirements (GSPR) matrix
  • Standards and common specification conformity mapping
  • Risk management file to ISO 14971
  • Biocompatibility and verification/validation evidence strategy
  • Labeling, IFU, and Summary of Safety and Clinical Performance (SSCP)
  • Technical documentation gap remediation
Clinical & Performance Evaluation

Where MDR and IVDR Programs Most Often Break Down.

The Clinical Evaluation Report for a device, and the Performance Evaluation Report for an IVD, are where notified bodies concentrate their scrutiny, and where thin evidence or a weak literature route triggers major deficiencies. Equivalence claims that once carried a legacy device rarely survive MDR. We build the evaluation plan, run the literature and data analysis, and write CERs and PERs to current MDCG guidance, identifying early whether you need clinical investigation or performance studies to close the gap.

Included Capabilities

  • Clinical Evaluation Plans and Reports (CEP/CER) under MDR
  • Performance Evaluation Plans and Reports (PEP/PER) under IVDR
  • Scientific validity, analytical, and clinical performance evidence
  • Systematic literature review and appraisal
  • Equivalence justification and gap analysis
  • Clinical investigation and performance study strategy
  • Alignment with MDCG guidance and notified body expectations

Technical file or CER heading to a notified body? Get senior eyes on it before you submit.

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Notified Body Strategy & Audit

The Notified Body Queue Is Now Part of Your Timeline.

A limited number of designated notified bodies review every device that needs one, and the wrong choice, or an unready application, can cost you a year. Notified bodies differ in scope, capacity, and the device types they know well. We help you select the right one, prepare an application that survives completeness review, and manage the technical and QMS audits, then turn deficiency letters around fast enough to keep certification on schedule.

Included Capabilities

  • Notified body selection by scope, capacity, and device type
  • Application readiness and completeness review
  • Stage 1 and Stage 2 audit preparation
  • Deficiency and nonconformity response management
  • Structured dialogue and pre-submission engagement
  • Certification maintenance, surveillance, and recertification audits
  • Notified body transfer strategy
Post-Market Surveillance & PMCF

Under MDR and IVDR, Surveillance Never Stops.

Both regulations demand a proactive, systematic post-market system: a PMS plan, ongoing clinical or performance follow-up, and periodic reports that feed straight back into your clinical evaluation. Notified bodies check that this loop is real and running, not a binder on a shelf. We build the PMS and PMCF/PMPF program, produce the PSURs and trend reports, and run the vigilance and reporting system so your surveillance data strengthens the next certification instead of undermining it.

Included Capabilities

  • Post-Market Surveillance (PMS) plans and reports
  • PMCF (devices) and PMPF (IVDs) plans, studies, and evaluation reports
  • Periodic Safety Update Reports (PSUR) and trend reporting
  • Vigilance, incident, and Field Safety Corrective Action reporting
  • Complaint handling and signal management systems
  • Feedback loop into clinical and performance evaluation
  • PMCF surveys and real-world data collection
QMS, UDI & EUDAMED

The Systems That Let You Legally Place a Device on the Market.

Certification assumes an ISO 13485 quality system behind it, and market entry assumes UDI assignment and EUDAMED registration in front of it. These operational pieces are where teams focused on the technical file lose time. We build or remediate the quality system MDR and IVDR require, set up UDI-DI assignment and labeling, and handle EUDAMED actor and device registration so nothing procedural holds up a device that is otherwise ready to sell.

Included Capabilities

  • ISO 13485 quality system implementation and remediation
  • MDR/IVDR-specific QMS procedures and readiness
  • Unique Device Identification (UDI-DI/UDI-PI) assignment
  • EUDAMED actor, device, and UDI registration
  • Person Responsible for Regulatory Compliance (PRRC) support
  • Economic operator (importer/distributor) obligation mapping
  • Labeling and Basic UDI-DI structure
Where Teams Get Stuck

Two Situations That Sink European Programs.

Beyond the core route to CE marking, two challenges account for most stalled European programs: transitioning legacy devices off the old directives, and standing up the in-market representation the regulations require.

Legacy Device Transition

An Old CE Certificate Is Not an MDR Certificate.

Thousands of devices certified under the old MDD, AIMDD, or IVDD still have to move to MDR or IVDR before their transition deadlines, and the leap is steep: up-classification, a rebuilt clinical or performance evidence base, and technical files that no longer pass. We assess the gap on each legacy product, prioritize the portfolio against deadlines and revenue, and run the remediation that keeps your existing devices on the European market.

Included Capabilities

  • MDD/AIMDD to MDR and IVDD to IVDR gap assessment
  • Portfolio prioritization against transition deadlines
  • Legacy technical file and CER/PER remediation
  • Up-classification impact and route change planning
  • Article 120 transition and sell-off provision strategy
  • Product rationalization and discontinuation decisions
EU Representation & Market Entry

You Cannot Sell in Europe Without the Right Actors in Place.

A non-EU manufacturer needs an Authorized Representative, a compliant importer and distributor chain, and a Person Responsible for Regulatory Compliance, each with defined legal duties under MDR and IVDR. Get the structure wrong and your device is not lawfully on the market, whatever the certificate says. We map the economic operator obligations, help you establish or vet an EU Authorized Representative, and set up the registration and agreements that make market entry real.

Included Capabilities

  • EU Authorized Representative (EC REP) setup and oversight
  • Economic operator role and obligation mapping
  • Importer and distributor compliance requirements
  • Person Responsible for Regulatory Compliance (PRRC) strategy
  • Mandate agreements and responsibility allocation
  • EUDAMED registration and market-entry readiness
Who You're Working With

People Who Have Sat on the Notified Body Side.

MDR and IVDR reward teams that know how a notified body reads a file, because they have been that reviewer. Our European practice is built from former notified body and competent authority staff and industry regulatory leaders who have carried devices and IVDs through certification. You get the senior reviewer who knows why files get held.

Former Notified Body Reviewers

Consultants who have assessed technical files and clinical evaluations from inside a notified body, and know exactly which gaps trigger a deficiency letter.

MDR and IVDR Depth

Practitioners fluent in both regulations, from Class I devices to Class D companion diagnostics, and in the MDCG guidance that keeps evolving.

Clinical and Performance Evidence

Specialists who write the CERs and PERs that survive scrutiny, and who know when the honest answer is that you need new clinical or performance data.

US-EU Bridging

Leaders who align FDA and European programs so one device strategy serves both markets instead of running as two disconnected projects.

Work With Us

Get Your Device to the European Market.

Tell us about your device or IVD, its classification, and your target deadline. We'll assess your route to CE marking and match you with a senior European regulatory lead, with a response within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on MDR & IVDR.

Our team's perspectives on CE marking, clinical evaluation, and the notified body process: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

Why Notified Bodies Reject Technical Files

The deficiencies that stall certification, and how to close them first.

Coming Soon

When Equivalence No Longer Survives MDR

How to tell early whether you need new clinical data for your CER.

Coming Soon

The IVDR Class D Evidence Burden

What high-risk assays now owe on scientific validity and performance.