Regulatory interface · Submission control · Response management
Make every regulatory interaction move the project forward
Prepare the right question, the supporting evidence and the decision record before you approach a notified body, competent authority or market regulator.
Role clarity
Identify who can assess, decide, advise or enforce
A productive interaction begins by addressing the correct organisation through the correct procedure. A notified body is not an EU regulatory authority, and an informal exchange is not a marketing decision.
European Union
Notified body
An independent organisation designated for defined MDR or IVDR conformity assessment tasks. Its designation scope and codes must cover the product and procedure. The current scope is checked in NANDO.
European Union
National competent authority
A public authority responsible for functions such as enforcement, market surveillance, vigilance and national procedures for clinical investigations or performance studies, depending on the matter and Member State.
United States
FDA review team
The relevant FDA centre and review division address classification, investigational and premarket submissions, Q-Submission feedback and lifecycle obligations within the applicable US procedure.
Local market structure
Applicant, holder or representative
Some procedures require a locally established applicant, registration holder, importer, authorised representative or US agent. Regulatory support does not replace a legally required local economic operator.
Commercial support scope
Control the communication from first approach to closed action
MDRC can support one critical exchange or manage the communication workstream across a longer conformity assessment, submission or remediation project.
Route and counterpart selection
Confirm the regulatory procedure, responsible organisation, reviewer scope, applicant role, language and submission channel.
Initial approach and application
Prepare a concise product profile, classification basis, requested scope, application data and supporting readiness package.
Meeting and advice preparation
Convert uncertainty into answerable questions, evidence summaries, briefing materials, speaking roles and desired decisions.
Submission coordination
Control the dossier structure, forms, correspondence, authorised sign-off, portal responsibilities and submission record.
Deficiency and question responses
Classify comments, assign owners, develop response logic, update evidence and maintain traceability to each closed point.
Lifecycle communication
Support significant-change assessment, certificate matters, vigilance, corrective actions, post-approval commitments and authority follow-up.
European Union
Keep conformity assessment and authority procedures on separate tracks
The tracks can interact, but they have different legal roles, submission routes and decision records. The project plan should state which party owns each question and what outcome is actually available.
Notified body engagement
- Confirm MDR or IVDR designation and relevant product or procedure codes
- Prepare product and company information for quotation and application
- Align QMS, technical documentation and sampling scope before review
- Coordinate audit and technical documentation questions
- Maintain a response matrix and objective evidence trail
- Assess changes and certificate implications after certification
Competent authority engagement
- Identify the competent authority and national contact point for the matter
- Prepare clinical investigation or performance study submissions where applicable
- Structure vigilance, field safety and corrective-action communications
- Prepare responses concerning market surveillance or compliance questions
- Coordinate derogation or other exceptional procedures where legally available
- Record authority correspondence, commitments and follow-up deadlines
EU expert panels can provide advice in defined circumstances, including on clinical development strategy for certain high-risk products. This is not a universal pre-submission procedure and should not be presented as binding approval.
Review the expert panel frameworkUnited States
Ask the FDA a decision-relevant question before locking the evidence plan
The Q-Submission Program provides mechanisms for written feedback or meetings related to planned medical device submissions. A Pre-Submission is voluntary, and the feedback is not itself clearance, classification or approval.
Frame the regulatory position
Identify the product code, intended use, technology, proposed pathway and decisions that need FDA feedback.
Build the question package
Present focused questions with sufficient background, proposed methods, supporting data and a clear sponsor position.
Prepare the interaction
Plan participants, speaking roles, evidence references, fallback questions and the points that require confirmation.
Control the record
Document written feedback or meeting outcomes, assess conditions and translate them into controlled development actions.
Interaction and submission types may include
Selected Latin American markets
Coordinate the authority package with the required local structure
Latin America is not one regulatory route. Classification, reliance options, language, local holder or importer roles, certificates and submission systems must be confirmed for each country and current procedure.
ANVISA
Classification, notification or registration route, reliance options, GMP evidence and locally controlled submission inputs.
↗ MexicoCOFEPRIS
Product route, dossier requirements, equivalence or reliance options, local applicant coordination and deficiency responses.
↗ ArgentinaANMAT
Product and establishment procedures, local applicant inputs, Spanish documentation and lifecycle communication.
↗MDRC coordinates the regulatory workstream with the manufacturer and the appropriately authorised local party. The legal applicant or registration-holder role remains with the entity permitted to perform it under national law.
Working method
Run the interaction as a controlled regulatory project
The objective is not more correspondence. It is a clear, evidence-based decision that can be implemented and traced through the dossier.
- 01
Define the decision
State what must be confirmed, by whom, under which procedure and by what project date.
- 02
Establish the regulatory position
Document the manufacturer's proposed interpretation, assumptions and supporting requirements.
- 03
Assemble the evidence
Select only the product, risk, testing and clinical information needed to answer the defined question.
- 04
Prepare and conduct the exchange
Control the package, participants, submission channel, meeting logic and contemporaneous notes.
- 05
Implement and close
Translate feedback into actions, owners, deadlines, dossier updates and a retained decision record.
Controlled outputs
Leave a record that survives personnel changes and later review
Counterpart and route memorandum
Responsible body, legal route, scope, applicant role, contacts, format and decision sought.
Briefing or submission package
Controlled questions, background, evidence summaries, manufacturer positions, forms and annexes.
Response matrix
Each comment linked to requirement, owner, response, revised evidence, approval and closure status.
Meeting record
Participants, discussion, regulator or reviewer feedback, conditions, open points and follow-up commitments.
Regulatory decision log
Decision, rationale, source, affected documents, product implications and change-control references.
Management status report
Current stage, dependencies, unresolved risks, upcoming deadlines and decisions required from the manufacturer.
Clear boundaries
Strong preparation does not mean promising the outcome
MDRC can improve the quality, consistency and traceability of an interaction. We cannot guarantee acceptance, certification, clearance, approval or a particular review timeline, and we do not replace the independent judgment of a notified body or public authority.
The manufacturer remains responsible for the product, its claims, submitted evidence and regulatory compliance. Where a legally authorised local party or official correspondent is required, roles are agreed before the submission.
Primary sources
Confirm the current procedure before each interaction
EU notified bodies
Designation, NANDO scope, monitoring and coordination
EU coordination and governance
Commission, competent authorities, MDCG and notified body structures
FDA Q-Submission Program
Current mechanisms for feedback and meetings on device submissions
FDA device market pathways
Classification, studies, premarket routes and lifecycle controls
ANVISA medical devices
Brazilian authority information for medical device regularisation
COFEPRIS medical devices
Mexican authority information, registration guidance and records
ANMAT medical products
Argentine authority systems, procedures and device information
Frequently asked questions
Working with external regulatory reviewers
The service scope is set around the product, market, procedure, project stage and parties legally permitted to make the submission.
Is an EU notified body a regulatory authority?
No. A notified body is an independent organisation designated to perform specified conformity assessment tasks when third-party involvement is required. National competent authorities perform public-authority and enforcement functions.
Can MDRC choose a notified body for us?
We can identify candidates by MDR or IVDR designation scope, codes, technology fit and practical availability. The manufacturer makes the appointment decision and contracts directly with the notified body.
Does an FDA Pre-Submission guarantee agreement?
No. It is a voluntary mechanism for obtaining FDA feedback. The feedback is not a marketing authorisation and does not guarantee the result of a later 510(k), De Novo, PMA, IDE or other submission.
Can MDRC manage deficiency responses?
We can classify comments, identify the underlying requirement, coordinate technical owners, draft or review responses and maintain traceability to revised evidence. The manufacturer approves the final response and remains responsible for its claims and evidence.
Can the same package be used in several markets?
The evidence core can often be reused, but questions, formats, language, applicant roles and legal procedures differ. We adapt the package without treating one market's conclusion as another market's decision.
Prepare the interaction
Bring us the question before it becomes a review delay
Send the product description, target market, current regulatory position, existing correspondence and the decision you need. We will propose a focused preparation and communication scope.
Discuss the regulatory interface