Regulatory Strategy
Clarify intended use, classification, evidence needs, regulatory route, and the work sequence needed before submission or launch.
MedTech and IVD regulatory consultancy
Medical device and IVD regulatory support for EU and U.S. market entry.
25 years of medical device and IVD regulatory and quality experience, across Class I to Class III, for EU and U.S. market entry.
Trusted by teams at
Services
Regulatory support across the full EU and U.S. pathway.
Most teams start where the timeline pressure is highest.
QMS & Inspection Readiness
Build or tune quality-system controls for ISO 13485, FDA QMSR alignment, supplier oversight, audits, and day-to-day operation.
Submissions & Market Entry
Prepare regulatory documentation, submission inputs, registration, and listing that support EU and U.S. market entry.
PRRC
Named PRRC role under MDR Article 15 / IVDR Article 15. Eligibility, responsibilities, documentation access, and escalation paths are defined before engagement.
Information Security
Security evidence, ISO 27001 scope, IEC 62304/81001 interfaces, and QMS controls for SaMD and connected-device teams.
U.S. FDA Agent
FDA communication and inspection liaison for foreign device establishments.
Regulatory updates · Last updated May 3, 2026
What changed for device and IVD teams.
EU and FDA changes for device and IVD manufacturers.
EUDAMED first four modules become mandatory on 28 May 2026
The European Commission notice starts the transition for actor registration, UDI/devices, notified bodies and certificates, and market surveillance modules.
FDA QMSR is effective under 21 CFR Part 820
The QMSR incorporates ISO 13485:2016 by reference and changes the quality-system baseline for finished device manufacturers.
FDA inspection approach changes alongside QMSR
FDA states it no longer uses QSIT for device inspections and now uses the updated medical-device manufacturer compliance program.
Latest articles
Recently published articles.
Recent regulatory articles on EU MDR/IVDR, FDA, QMS, and inspection readiness, written to help you decide what matters before you act.
Working method
How CENIT structures the work.
Every engagement starts from the product, market, evidence, QMS state, and launch milestone. The regulatory work is then sequenced around clear dependencies.
Assessment
Clarify product, jurisdiction, current evidence, QMS state, and the launch milestone driving the work.
Regulatory plan
Turn regulatory, quality, software, and submission needs into a staged plan with clear dependencies.
Documentation & QMS
Create or improve the procedures, files, rationale, evidence plans, and operating controls needed for the pathway.
Submission & audit support
Support submissions, audits, registrations, named roles, and questions from regulators or partners.
Post-market maintenance
Maintain post-market, QMS, update monitoring, and change-control activity after the first milestone.
Common situations
Where CENIT helps.
Market-entry planning EU MDR, IVDR, or FDA pathway questions before fundraising, partner diligence, or launch planning.
QMS readiness ISO 13485, FDA QMSR, supplier oversight, internal inspection preparation, or quality-system cleanup.
Submissions and registration Technical documentation, submission inputs, registration, listing, or evidence planning.
PRRC or U.S. FDA Agent PRRC under MDR/IVDR, or U.S. FDA Agent appointment for a foreign device establishment.
Named roles
Named accountability under MDR/IVDR and U.S. FDA rules.
PRRC applies to MDR/IVDR obligations. U.S. FDA Agent applies to foreign device establishments entering the U.S. market.
European UnionEU
PRRC
For EU manufacturers or authorised representatives that need a named PRRC under MDR Article 15 or IVDR Article 15.
Engagement defines eligibility, scope of authority, documentation access, escalation paths, and notice periods before signing.United StatesU.S.
U.S. FDA Agent
U.S. FDA Agent appointment for foreign device establishments. Acts as the FDA communication and inspection liaison defined under 21 CFR 807.40.
Scoped to FDA liaison duties; does not include submissions, market authorisation, or quality-system responsibility.The first consult
What the first consult covers.
CENIT reviews product, jurisdiction, current gaps, and whether a defined engagement makes sense before any proposal is issued.
Initial review
Product, jurisdiction, current evidence, QMS state, and the launch milestone are reviewed in 30 minutes.
Defined deliverables and role boundaries
If the engagement proceeds, deliverables, role responsibilities, documentation access, and escalation paths are set in the engagement scope.
Book a 30-minute regulatory consult
Review product, jurisdiction, and current gaps. Scope is defined in writing before work begins.