Sectors & Regulatory Expertise
From IVD startups to global pharma, MDx CRO delivers clinical, regulatory, and quality services across every corner of the MedTech landscape. Deep sector knowledge means fewer surprises, faster approvals, and stronger submissions.
Regulatory Expertise Across the MedTech Ecosystem
Every device type brings its own regulatory logic, different classification rules, different clinical evidence expectations, and different Notified Body dynamics. MDx CRO operates across the full MedTech spectrum, so we understand not just the regulations, but how they apply differently depending on whether you are bringing a Class D companion diagnostic, a SaMD product, or a Class III implant to market.
MDR compliance, clinical evaluation, and CE marking for Class I to Class III devices — including implants, surgical instruments, and combination products.
End-to-end IVD support under IVDR: from analytical validation and clinical performance studies to technical documentation and Notified Body submissions for Class A through Class D.
Clinical performance studies, regulatory submissions, and site monitoring for companion diagnostics under IVDR Annex XIV and in alignment with FDA requirements, supporting combined drug-diagnostic trials with top pharma sponsors.
VDR transition support, ISO 15189 compliance, LDT regulatory pathways, and lab qualification for clinical performance studies under ISO 20916.
SaMD classification, IEC 62304 lifecycle compliance, AI Act alignment, and cybersecurity documentation for digital health products under MDR and IVDR.
Since our founding in 2021, MDx CRO has grown into a cross-sector regulatory and clinical partner for IVD manufacturers, pharma sponsors, and medical device companies across Europe and beyond.
Standards and Guidance That Shape Every Submission
MDR and IVDR set the legal requirements, but it is the ISO standards and MDCG guidance documents that define how those requirements are met in practice. We maintain dedicated knowledge hubs for the frameworks our team applies daily, so you can understand what your Notified Body expects before they ask for it.
Our complete reference to the ISO and IEC standards that govern MedTech and IVD compliance — from ISO 13485 and ISO 14971 to ISO 20916 and IEC 62366. Each standard explained by the team that applies them in practice.
Practical breakdowns of the Medical Device Coordination Group guidance that shapes how MDR and IVDR are interpreted — including MDCG 2020-13, MDCG 2019-11, and MDCG 2021-24.
Why Sector Expertise Matters in MedTech Regulatory Affairs
Regulatory compliance in the medical device and IVD industry is not one-size-fits-all. A companion diagnostic pursuing CE marking under IVDR Annex XIV faces a fundamentally different regulatory pathway than a Class IIa surgical instrument under MDR, different classification rules, different clinical evidence requirements, different Notified Body expectations, and different timelines.
This is why sector specialisation matters. A CRO that understands the specific regulatory landscape of your product type can anticipate the questions a Notified Body will ask, identify the standards that apply to your device, and structure your technical documentation to meet expectations on the first submission, not the third.
At MDx CRO, our team includes former Notified Body reviewers, clinical research specialists, and regulatory affairs professionals who have worked across the full spectrum of MedTech sectors. We bring this cross-sector perspective to every project, whether it involves a single-site analytical performance study for an IVD startup or a multi-country clinical performance study for a global pharma company’s companion diagnostic programme.
Our regulatory knowledge is not theoretical. It is built on direct experience with the standards and guidance documents that underpin MDR and IVDR compliance. We maintain dedicated knowledge hubs for the ISO and IEC standards and MDCG guidance documents most relevant to our clients, not as static references, but as living resources informed by the projects we deliver every day.
Whether you are an IVD manufacturer preparing your first IVDR submission, a MedTech company transitioning from MDD to MDR, or a pharma sponsor coordinating a combined clinical trial with a companion diagnostic study, MDx CRO has the sector expertise to guide you through it.
Find the Right Expertise for Your Device
Tell us about your product and regulatory challenge. We will connect you with the right specialist from our team, whether you need clinical, regulatory, or quality support.
