European Union · Clinical Evaluation (MDR)
Clinical Evaluation Report (CER) — EU MDR-aligned
Under the EU Medical Device Regulation (MDR), every device must have a clinical evaluation—a planned, ongoing process that collects, appraises and analyses clinical data to show the device’s safety and performance. The conclusions are documented in a Clinical Evaluation Report (CER), which is part of the technical documentation and supports conformity with the General Safety and Performance Requirements (GSPRs).
Sobel structures and authors the end-to-end package: we draft the Clinical Evaluation Plan (CEP), run a systematic literature review, extract and appraise all relevant data (favourable and unfavourable), build concise evidence tables, use equivalence only when fully justified, write a transparent benefit–risk narrative, and define PMCF links that keep your CER current.
Clinical Evaluation Plan (CEP)
Systematic literature review
Appraisal & analysis
Equivalence (if justified)
Benefit–risk & PMCF linkage
A lifecycle CER that notified bodies can follow and maintain.
- CEP
- Identify & appraise data
- Analyse & conclude
- CE
- PMCF keeps CER current
What You Will Receive
The focus is simple: DI records entered into GUDID correctly and based on the data you provide.
What you will receive
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Mapping of your existing UDI information (DI, issuing agency) to GUDID fields.
- Structuring basic device and packaging data (brand, model/version, packaging levels, key attributes) in a format GUDID expects.
- Short list back to you of any obvious gaps or inconsistencies to resolve before we enter the data.
Systematic literature package:
Search strategies, inclusion/exclusion, PRISMA-style flow, extraction tables, and critical quality appraisal.
- Entry of your DI records into GUDID using the FDA web application and your account.
- Completion of required fields and key conditional elements, based on your instructions and supporting data.
- Basic on-screen checks so GUDID accepts the entries (no separate HL7 SPL build or automation).
Clinical Evaluation Report (CER):
Appraisal & analysis, transparent benefit–risk narrative, equivalence rationale (if used), and a PMCF linkage.
- A short note on when you should update a DI (e.g., label changes, packaging changes, discontinuation) vs. deactivate it.
- A basic checklist you can re-use when adding new DIs in the future.
Scope: Consulting and documentation only. We do not conduct clinical investigations or act as a notified body.
Device records registered in EUDAMED using your own identifiers and data.
Label & IFU Confirmation
- Check that BRH identification appears correctly on labels and IFUs, as required.
- Support for electronic IFU portal upload where applicable.
- Basic alignment of regulatory text in labels/IFUs with the granted registrations/notifications.
Change & Revalidation Plan
- Categorize post-approval changes (approval-required, immediate implementation, non-reportable) under RDC 751/2022.
- Maintain a calendar and tracking logic for 10-year registration validity and revalidation.
- Outline a simple governance model so technical and commercial teams know when to involve the BRH.
Vigilance & Field Actions Routing
- Define who reports what, to whom, and when for Brazil-specific vigilance signals and field actions.
- Clarify timelines and roles for ANVISA notifications, customer communications, and follow-up reporting.
- Ensure vigilance documentation supports registration and labeling obligations.
How we work
We keep the process straightforward: prepare the data, enter it in GUDID, and hand back a clear overview.
Plan:
- Confirm your GUDID account access (submitter/coordinator) and labeler role.
- Collect your UDI information (existing DI and issuing agency) and a product list with basic attributes and packaging levels.
Collect & appraise:
- Map your UDI and product details into the GUDID data structure.
- Flag any missing essentials for you to confirm or correct.
Analyse & conclude:
- Log into your GUDID web account and enter DI records on your behalf.
- Complete required fields and save the entries so they appear in GUDID and AccessGUDID.
Link to PMCF:
- Provide you with a simple list of DIs registered and key attributes entered.
- Share a short checklist for adding or updating DIs on your own going forward.
Label/IFU confirmation
Maintenance & vigilance
Key terms
- Clinical Evaluation: Planned, ongoing process to collect, appraise and analyse clinical data showing safety and performance.
- CER (Clinical Evaluation Report): The report that documents your clinical evaluation conclusions for the technical documentation.
- CEP (Clinical Evaluation Plan): The plan defining purpose, methods, data sources, outcomes, and acceptance criteria for the evaluation.
- PMCF (Post-Market Clinical Follow-up): Planned post-market activities to keep evidence current and feed CER updates over the lifecycle.
Scope & Exclusions
We keep the service precisely defined so your internal team, Sobel, and your partners in Brazil understand who does what—and where additional services might be needed.
In Scope
- Consulting and documentation support for medical device market access and authorization in Brazil.
- Development of a Brazil-specific regulatory and market access strategy.
- Organization and structuring of a Brazil-ready documentation package based on your existing evidence.
- Alignment and regulatory review of core Portuguese label and IFU content.
- Coordination of roles and responsibilities with local Brazilian partners involved in regulatory processes.
Out of Scope
- Acting as a government authority or making regulatory decisions on behalf of ANVISA.
- Acting as your Brazilian Registration Holder (BRH) or equivalent local legal entity, unless contracted separately via a dedicated service.
- Laboratory testing or generation of new technical or clinical evidence.
- Full marketing translations, graphic label design, printing, and commercial artwork creation beyond regulatory text alignment.
Inputs We Need From Your Team
- Clear description of your devices, intended purpose, and key claims.
- Overview of models/variants and how you plan to position them in the Brazilian market.
- Available technical and regulatory documentation, including evidence and applied standards.
- Existing label and IFU content (or source text) to be aligned to Portuguese and to Brazilian expectations.
- Information on your current or planned local partners and legal representatives in Brazil.
- Internal timelines, priorities, and constraints for Brazil market entry.
Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.
When You Need a Brazilian Registration Holder
Typical situations where appointing a BRH becomes essential for Brazil market access:
- You are a foreign medical device manufacturer without a Brazilian legal entity but want to place devices on the Brazilian market.
- You need a single, stable license holder that is not tied to any one distributor, so you can keep commercial options open.
- You want to file notifications/registrations under RDC 751/2022 and maintain them over time, including changes and revalidation.
- You need someone to be clearly identified on Brazilian labeling/IFU as the holder responsible before ANVISA.
- You want vigilance and field actions in Brazil to follow defined timelines and routing, without ad-hoc email chains.
FREQUENTLY ASKED QUESTIONS
Yes. Every device requires a clinical evaluation with conclusions documented in the CER; depth varies by risk, claims and evidence.
No. Start with existing data; generate new data only if justified. Equivalence is acceptable only when MDR conditions are fully met.
Keep it current via PMCF and PMS. Set a review cadence based on risk, claims and evidence dynamics.
Plan my CER
We’ll reply with a proposed slot and a short intake checklist.
Consulting & documentation only; we do not conduct clinical investigations or act as a notified body.
Contact Us
We would love to speak with you.
Feel free to reach out using the below details.
