Skill Profile
MDR/FDA Regulatory Submissions
"The observable action of compiling, structuring, and submitting the technical documentation, clinical evidence, and quality system records required by the EU Medical Device Regulation (MDR 2017/745) and US FDA device regulatory pathways — so that a medical device achieves and maintains market authorisation in compliance with applicable regulatory requirements."
YOUR SKILLS
Problems This Skill Solves
- Market access failure caused by incomplete or non-compliant technical documentation — systematic compilation of the technical file or Design Dossier to MDR and FDA requirements ensures that submissions contain all required elements and can withstand regulatory scrutiny, avoiding delays and costly resubmissions
- Device classification errors that result in the wrong regulatory pathway — accurate classification under MDR Annex VIII classification rules and FDA device classification databases determines which regulatory pathway (CE marking route, 510(k), PMA, De Novo) is required, preventing projects from being designed around the wrong regulatory strategy
- Clinical evidence shortfalls that block MDR certification — systematic clinical evaluation planning under MDR Article 61 and MEDDEV 2.7.1 Rev 4 requirements identifies clinical evidence gaps early, enabling clinical investigations or systematic literature reviews to be planned and executed in time to support the submission
- Post-market surveillance failures that risk CE mark withdrawal or FDA enforcement action — MDR-compliant post-market surveillance plans and FDA MDR (Medical Device Reporting) systems that systematically collect and analyse real-world device performance data demonstrate ongoing compliance and identify safety signals before they trigger regulatory action
Tools Used
Roles That Use This Skill
1 total · 1 industryThis skill is concentrated in one industry.
Medical Devices / Healthcare / Research
"MDR/FDA submissions are primarily a documentation exercise — it's about filling in the right forms and compiling the right paperwork in the right order."
The documentation that constitutes a regulatory submission is the output of substantive technical, clinical, and quality work — not the work itself. A 510(k) submission is legally valid only if the substantial equivalence claim is accurate and supported by genuine comparative performance data; an MDR technical file demonstrates conformity only if the clinical evaluation is based on sufficient, appropriate clinical evidence; a risk management file satisfies ISO 14971 only if the risk assessment genuinely reflects the device's hazards and the risk control measures are technically adequate. Regulators who review submissions — Notified Body assessors, FDA reviewers — are technically trained and evaluate the substance of the underlying work, not just its formatting and completeness. The regulatory affairs professional's role is therefore to understand the substantive technical and clinical requirements well enough to judge whether the work is genuinely compliant, direct cross-functional teams to address gaps, and communicate the evidence compellingly in the submission format — not merely to assemble documents that look complete.
Research & Outlook
Medical device regulatory affairs is in a period of sustained upheaval following the full implementation of EU MDR 2017/745 and EU IVDR 2017/746, which imposed substantially higher clinical evidence requirements than the former MDD/AIMD directives and created significant Notified Body capacity constraints — driving many device manufacturers to seek regulatory affairs expertise urgently to manage the transition of their product portfolios to the new requirements. The FDA's Digital Health Center of Excellence and the growing regulatory framework for AI/ML-based Software as a Medical Device (SaMD) — including the FDA's proposed Predetermined Change Control Plan approach — is creating a new regulatory specialism for software and algorithm-based devices that does not fit neatly into the traditional hardware device regulatory framework. The UK's post-Brexit UKCA marking regime and the Medicines and Healthcare products Regulatory Agency's (MHRA) development of an independent UK medical device regulatory framework is adding a further jurisdictional requirement for EU and US device manufacturers seeking UK market access.
See This Skill In Action
Watch a professional demonstrate MDR/FDA Regulatory Submissions in a real working environment — what it looks like, how it's applied, and why it matters.
Regulatory Affairs / Medical Devices
MDR/FDA Regulatory Submissions
Also Known As
Growth Path
Compiles and formats sections of a technical file or 510(k) submission under the direction of a senior regulatory affairs professional. Understands device classification rules and the basic structure of MDR and FDA regulatory pathways. Maintains the Document Management System for regulatory files. Prepares routine correspondence with Notified Bodies and FDA. Understands the key harmonised standards relevant to the device types they work on.
Leads the preparation of complete regulatory submissions for Class IIa/IIb (MDR) and Class II (FDA) devices independently. Develops the regulatory strategy for new device programmes. Manages Notified Body technical reviews and FDA submission Q&A cycles. Designs and manages the clinical evaluation process under MDR Article 61. Establishes and maintains MDR-compliant post-market surveillance systems. Advises cross-functional teams on regulatory requirements.
Leads global regulatory strategy for Class III (MDR) or PMA-class (FDA) devices, including first-in-class or novel technology submissions. Manages multi-jurisdictional regulatory programmes across EU, US, and additional markets (UK MDR, Health Canada, TGA) simultaneously. Represents the company in regulatory authority meetings (Notified Body, FDA Pre-Submission, Scientific Advice). Serves as the EU Person Responsible for Regulatory Compliance (PRRC) or equivalent. Advises the board on regulatory risk and market access strategy.
How to Practise
- 1.Work through a fictional Class IIa (MDR) or Class II (FDA) device regulatory submission end-to-end: complete a device description, classification justification, intended purpose statement, risk management file (ISO 14971), clinical evaluation plan, instructions for use, and post-market surveillance plan — using publicly available device files and FDA Summary of Safety and Effectiveness Documents (SSEDs) as reference benchmarks.
- 2.Read recent Notified Body audit findings and FDA Warning Letters for medical device companies — understanding the specific non-conformances that regulators find (incomplete clinical evidence, inadequate risk management, poor PMCF planning) develops practical knowledge of where submissions most commonly fail.
- 3.Study the MDCG guidance documents (freely available on the European Commission website) that clarify MDR requirements in detail — particularly MDCG 2020-1 (clinical evaluation), MDCG 2021-24 (PMCF), and MDCG 2022-2 (post-market surveillance) — which are the primary reference documents for MDR compliance.
- 4.Complete the TOPRA Certificate of Regulatory Affairs, RAPS Regulatory Affairs Certification (RAC), or an MSc in Regulatory Affairs for Medical Devices — providing the systematic theoretical and practical grounding for professional regulatory submissions work.
How to Prove
- ·RAC (Regulatory Affairs Certification) from RAPS — the globally recognised professional qualification for regulatory affairs professionals, demonstrating assessed competence in regulatory science and submissions
- ·TOPRA Certificate or MSc in Regulatory Affairs — the UK and European professional qualifications for regulatory affairs practitioners, demonstrating systematic training in medical device and pharmaceutical regulation
- ·Regulatory submissions portfolio — documented evidence of successful CE mark certifications (MDR or MDD), 510(k) clearances, or PMA approvals contributed to or led, with reference from the Regulatory Affairs Director or responsible Notified Body reviewer
- ·ISO 13485 Lead Auditor qualification — demonstrating competence in quality management system auditing, which is foundational to understanding what regulatory submissions must demonstrate about quality system compliance