Clinical Evaluation & EU MDR Toolkit: CER, PMCF & Biocompatibility
Complete clinical evaluation toolkit with CER templates, PMCF plans, biocompatibility assessment, and EU MDR Article 61 compliance guidance.
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FDA Inspection Readiness Checklist
27-point checklist based on real 483 observations
Quarterly Regulatory Updates
Free updates when FDA guidance changes
Implementation Quick-Start Guide
Step-by-step instructions to deploy templates in your QMS
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Is This For You?
This toolkit is designed for teams facing these challenges:
Who This Is For
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Frequently Asked Questions
What file formats are included?
All 8 templates are in Microsoft Word (.docx) format. The Literature Appraisal Checklist and Equivalence Assessment are structured tables exportable to Excel for data management.
Which regulations and guidance does this cover?
EU MDR Article 61 and Annex XIV (clinical evaluation), MEDDEV 2.7/1 revision 4, ISO 10993-1:2018 (biocompatibility), and ISO 14155:2020 (clinical investigations). Aligned with current MDCG guidance documents.
Who is this for?
RA professionals writing CERs, clinical affairs specialists, companies seeking EU MDR Class IIa+ certification, and anyone whose CER was rejected or questioned by a Notified Body. Also valuable for US companies preparing for EU market entry.
Do I need clinical trials to use this toolkit?
Not necessarily. Many devices can achieve sufficient clinical evidence through systematic literature review and equivalence to predicate devices. The CEP Template helps you determine the right evidence strategy before starting.
How long should a CER be?
Quality over length: simple Class IIa devices typically need 30-60 pages; complex implants or Class III devices may need 100-200+ pages. The template includes guidance on proportionate depth by device class.
What makes a strong equivalence argument?
The Equivalence Assessment Template requires you to demonstrate equivalence across all three dimensions: clinical (same intended purpose), biological (same materials/contact), and technical (same design characteristics). All three must hold — one gap requires clinical data.
How does this integrate with post-market surveillance?
The PMCF Plan in this toolkit is designed to be consistent with your PMS Plan. PMCF fills the clinical evidence gaps the CER identifies. Cross-reference fields are included in both documents.
Will I get updates when MDCG CER guidance changes?
Yes — free updates by email when MDCG issues revised clinical evaluation guidance. EU MDR clinical evidence requirements continue to evolve.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund within 7 days — email support@regwatchdaily.com.
How does this compare to outsourcing CER writing?
Clinical evaluation writing services charge $15,000-50,000+ per CER. These templates enable your internal team to write a NB-quality CER — or dramatically reduce consultant hours if you do engage external support.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
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7-Day Iron-Clad Guarantee
Download everything. Review every template. If it doesn't save you at least 40 hours of documentation work, email us for a full refund. No questions. No hassle.
Every week without proper documentation is another week of audit exposure.