Medical Device & IVD Regulatory Services
We classify devices, compile technical documentation, manage conformity assessment, and coordinate with Notified Bodies through to CE marking and beyond. This covers medical devices under MDR and in vitro diagnostics under IVDR, including companion diagnostics and IVDs used in drug clinical trials. For international markets, we adapt the EU documentation and manage registrations with FDA, Health Canada, TGA, and other authorities through regulanet®. We don't hand over a strategy document and leave you to execute it. We compile the technical file, prepare the GSPR checklist, submit to the Notified Body, handle the questions, and get you to the certificate.
Visitors who previously worked with CE plus will find the same teams and expertise here. CE plus has been fully integrated into regenold, and all device, IVD, and software capabilities continue under the regenold brand.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
EU device market entry
You are bringing a medical device to the EU market for the first time and need someone to own the regulatory pathway from start to finish. Product classification, conformity assessment route selection, technical documentation compilation, Notified Body selection, and the entire submission and review process need to be planned, executed, and managed. You need a team that does this and not one that "tells you how to do it".
MDR transition
You have devices on the market under MDD certificates and need to transition to MDR before they expire. The technical documentation needs restructuring against Annex II/III, clinical evaluation gaps need identifying, and a phased transition plan with Notified Body submission timelines needs to be realistic and executable across the portfolio.
Legal manufacturer setup
You are a manufacturer outside the EU and need market access, but you have no EU entity, no ISO 13485 QMS, and no Notified Body relationship. You need a partner who handles the regulatory pathway and can also provide the EU infrastructure: Legal Manufacturer, EC REP, or both. For the legal representation roles, see Legal Representation.
Device classification
Your product sits at a classification boundary. It could be Class I self-declared or Class IIa requiring Notified Body involvement, or it could be a drug or cosmetic rather than a medical device. You need a defensible classification with documented rationale and, if necessary, competent authority engagement to resolve the question before you invest in the wrong regulatory pathway.
Notified Body query responses
Your Notified Body has raised questions or conditions during the technical documentation review, and you need structured responses with updated documentation, delivered within the review timeline. You need someone who understands what the NB is asking and how to close the issue without triggering further rounds.
IVD in drug trials
You are a pharmaceutical company running a drug clinical trial that uses an IVD for patient selection or treatment decisions. You need to understand whether IVDR applies, which regulatory pathway to follow (clinical performance study, in-house test, or CE-marked assay), and how to integrate the diagnostic requirements into the drug trial without delaying the program.
Understanding Medical Device & IVD Regulatory Services
The technical documentation is the central deliverable in device regulation, but it draws on work from multiple disciplines including design control, clinical evaluation, risk management, biocompatibility, usability, software lifecycle, and post-market surveillance. This page covers the regulatory pathway and the compilation of the technical documentation itself. It applies equally to medical devices under MDR and in vitro diagnostics under IVDR, including the regulatory interface between IVDs and drug clinical trials (the CTR-IVDR interface) and companion diagnostic co-development. For the IVD-specific regulatory landscape (IVDR classification, transition deadlines, CDx under IVDR), see the IVD & Companion Diagnostics page.
The specialist inputs come from dedicated teams with their own service pages: Clinical evidence (clinical evaluation reports, clinical investigations, PMCF studies) is covered on Clinical Development and Medical & Scientific Writing. The quality management system (ISO 13485, Notified Body audit preparation) is covered on Quality & Compliance. Risk management (ISO 14971) and usability engineering (IEC 62366-1) sit on Risk Management & Human Factors. Post-market technical documentation maintenance, design change assessments, and Notified Body re-certification after initial CE marking are covered on Post-Approval & Lifecycle Management.
For pharmaceutical regulatory operations (CTD, eCTD, marketing authorisation procedures, variations), see Regulatory Strategy & Operations. For combination products, the pharma and device regulatory teams coordinate internally.
What We Do
We manage the device regulatory pathway from classification through CE marking. The technical documentation is assembled from inputs across clinical, preclinical, quality, and risk management teams; our role is to define the structure, ensure internal consistency, coordinate the inputs, compile the final file, and manage the Notified Body process.
Our Workstreams
We structure device regulatory work into defined workstreams. Most engagements combine several of these, particularly for new devices going through initial conformity assessment.
Classification & Pathway
MDR classification under Annex VIII implementing rules. IVDR risk classification (A/B/C/D). Borderline product assessment (e.g., device vs. cosmetict, device vs. medicinal product). Competent authority engagement on contested classifications. Conformity assessment route selection and documentation.
Technical Documentation
Annex II TD compilation and structuring: device description, design and manufacturing information, GSPR mapping, labelling and IFU, benefit-risk determination, product verification and validation summaries. Annex III post-market surveillance documentation. Declaration of Conformity preparation. Cross-referencing and consistency checks across the entire file.
Notified Body Management
NB selection based on scope, capacity, and device-type experience. Pre-submission engagement. Submission package preparation and delivery. Review cycle management. Structured response to questions and conditions. Certificate issuance coordination and ongoing certificate maintenance.
EUDAMED & UDI
SRN (Single Registration Number) registration. Actor registration in EUDAMED. UDI-DI assignment through issuing entities (GS1, HIBCC, ICCBBA). Device registration in the UDI/device registration module.
International Registration
FDA regulatory pathway assessment (510(k), De Novo, PMA). Predicate device analysis and substantial equivalence argumentation for 510(k). Health Canada Medical Device Licence applications. TGA registration. NMPA submissions. Documentation adaptation from EU TD to local formats. Coordinated through regulanet® for markets outside Regenold's direct footprint.
IVDR Transition
Legacy IVD reclassification under IVDR Annex VIII. Gap assessment against IVDR Annex II/III requirements. Performance evaluation strategy (analytical performance, clinical performance, scientific validity). Common specifications alignment for Class D devices. EU Reference Laboratory involvement planning. Transition timeline management.
CTR-IVDR Interface & CDx
Regulatory pathway assessment for IVDs used in drug clinical trials: clinical performance study (CPS) applications, in-house test (IHT) set-up under IVDR Article 5(5), suitability assessment of CE-marked assays. Integration in drug scientific advice meetings. National demarcation procedures (e.g., German MPDG Article 6(3)). For companion diagnostics: EMA or NCA consultation coordination (IVDR Article 48), drug-diagnostic timeline alignment, co-development and bridging strategies. Diagnostic partner liaison and oversight for pharma sponsors. International scalability of testing solutions across EU, UK, and US.
Where This Fits in the Development Journey
Device regulatory work runs from early development through to market access and feeds into post-market lifecycle management.
Design & Development
Classify the device. Select the conformity assessment route. Define the TD structure and GSPR mapping framework. Begin compiling the technical documentation in parallel with design and development. Coordinate verification & validation activities. Engage with Notified Bodies early where possible.
Clinical (& Validation Studies)
Integrate clinical evidence (CER/PER, clinical investigation results, performance study data) into the technical documentation as it becomes available. Coordinate with clinical and writing teams on evidence requirements for NB submission.
Regulatory Submission & Approval
Finalise the technical documentation. Submit to the Notified Body. Manage the review cycle, handle questions and conditions, and coordinate through to CE certificate issuance.
Launch & Market Access
EUDAMED registration and UDI compliance. Declaration of Conformity. International registrations for non-EU markets (FDA, Health Canada, TGA, others via regulanet®).
Post-Market & Lifecycle Management
Hand over to Post-Approval & Lifecycle Management for ongoing TD maintenance, design change assessments, NB re-certification, and IVDR transition activities for legacy IVDs.
Product Type Considerations
The regulatory pathway differs substantially by device type. The classification, the conformity assessment route, the clinical evidence expectations, and the NB scrutiny all depend on what you are developing.
Implantable devices (Class III)
Clinical investigations are often required unless equivalence can be demonstrated (increasingly difficult under MDCG 2020-5). SSCP required. Highest NB scrutiny, longest review timelines, most extensive clinical evidence expectations.
In-vitro diagnostics (IVDs)
IVDR classification (Class A, B, C, D) determines the conformity assessment requirements. Class B, C and D require NB involvement with particular emphasis on performance evaluation (analytical, clinical, scientific validity). Class D devices may require EU Reference Laboratory feedback. Common specifications apply where designated. Legacy IVD transition timelines remain a major industry challenge.
Combination products
Primary mode of action determines the lead regulatory framework. For device-led combinations, we manage the conformity assessment and coordinate with the Regulatory Strategy & Operations team for the pharmaceutical component (Rule 14 products, consultation procedure). For drug-led combinations, the pharma team leads; we provide the device input (Article 117, Notified Body Opinion).
Custom-made devices
No routine Notified Body involvement, except for Class III custom-made implantable devices. Manufacturer must follow Annex XIII requirements, prepare a statement (Annex XIII, Section 1), and make documentation available to competent authorities on request. Reduced documentation requirements but full GSPR compliance still applies.
Non-implantable Class IIa/IIb
Literature-based clinical evaluation may be sufficient for well-established technologies. NB scrutiny is proportionate to the risk class but still rigorous under MDR.
Software as a Medical Device (SaMD/MDSW)
Classification depends on intended purpose and risk (MDCG 2019-11 decision rules). IEC 62304 and IEC 81001-5-1 compliance are inputs to the TD. EU AI Act creates additional obligations for AI/ML-based devices from August 2026. For the software-specific regulatory and lifecycle requirements, see Software as a Medical Device & Cybersecurity.
Substance-based devices
Substance-based products with a non-pharmacological, non-immunological, non-metabolic principal action can qualify as devices (often Rule 21, class IIa/IIb/III), but borderline with medicinal products is common and must be justified per MDCG 2022-5. Annex IX is typically the default route, with strong focus from Notified Bodies on mechanism-of-action justification, the robustness of literature regarding ADME, local tolerance and interaction, and clinical data, especially where legacy MDD classifications are being ported to MDR.
Sample Deliverables
The scope depends on the device, the classification, and the target markets. These are typical outputs from our device regulatory engagements.
Complete technical documentation per MDR / IVDR Annex II for initial Notified Body submission, structured and cross-referenced for NB review. 
GSPR compliance checklist (MDR / IVDR Annex I) with specific cross-references to supporting evidence across the technical file. 
Classification rationale document with implementing rule analysis, intended purpose documentation, and competent authority correspondence record. 
Notified Body submission package: cover letter, technical documentation, supporting correspondence, and coordinated QMS audit documentation. Structured response package to Notified Body questions or conditions, with updated TD sections, revised evidence summaries, and change tracking. EUDAMED registration package: SRN registration, UDI-DI assignment documentation, device registration records. 
FDA 510(k) submission adapted from EU technical documentation, including e.g., predicate device comparison, substantial equivalence argumentation, and FDA-format performance data summaries. 
IVDR transition gap assessment: product-by-product analysis of legacy IVDs against IVDR requirements, prioritised remediation plan, and phased transition timeline. Example Projects
Class IIb implantable device: full regulatory pathway from classification to CE marking
A medical device manufacturer developed a new Class IIb implantable device and needed the complete regulatory pathway managed. We classified the device, selected the conformity assessment route (Annex IX), compiled the full technical documentation including GSPR mapping, coordinated clinical evaluation and biocompatibility inputs from the clinical and preclinical teams, selected and engaged the Notified Body, managed the submission and two rounds of NB questions, and delivered the CE certificate within the planned timeline. The same technical documentation provided the basis for the subsequent FDA 510(k) submission.
MDR transition for a mixed-class device portfolio
A mid-size manufacturer with 15 devices ranging from Class I to Class IIb needed to transition from MDD to MDR. We assessed each device's technical documentation against MDR Annex II/III requirements, prioritised the portfolio by transition deadlines and commercial importance, developed a phased transition roadmap with Notified Body submission timelines, and managed the documentation updates and NB submissions over 18 months. All devices could be placed on the market on a continuous basis throughout the duration of the process.
EU-to-US market expansion via FDA 510(k)
A European manufacturer of a Class III surgically invasive device wanted to enter the US market. We assessed the FDA regulatory pathway, identified the predicate device, prepared the substantial equivalence argumentation, adapted the EU verification & validation data into FDA-format summaries, and compiled the 510(k) submission. The device was cleared on the first review cycle without additional information requests.
Planning a CE Marking Pathway, Preparing for a Notified Body Submission, or Managing an MDR / IVDR Transition?
Tell us about your device and where you are in the process, and we'll outline how we can help.
Speak with an ExpertKey Regulations & Guidance
These are the regulatory frameworks and guidance documents that most directly shape our device regulatory work:
Frequently Asked Questions (FAQ)
What does the conformity assessment procedure include, and how long does it take?
The process depends on the device class and conformity assessment route. It typically involves the Notified Body reviewing the technical documentation and conducting a QMS audit, followed by one or more rounds of questions. From submission to certificate, expect 6 to 24 months depending on the NB's current workload, the quality of the submission, and the complexity of the device. We manage the entire cycle: submission, questions, responses, and follow-up.
How do you select a Notified Body?
We assess NB capacity (current queue times), scope of designation (whether the NB is designated for your device type and MDR / IVDR Annex), geographic preference, experience with similar devices, and fee structure. Not all Notified Bodies accept all device types, and queue times vary significantly. We maintain current knowledge of NB capacity across the major designated bodies and advise on the selection that balances timeline, cost, and review quality.
What is GSPR mapping and why does it matter?
The General Safety and Performance Requirements (Annex I of the MDR/IVDR) define what a device must achieve: safety, performance, design, labelling, and information requirements. GSPR mapping means systematically documenting how each applicable requirement is met, with specific cross-references to supporting evidence in the technical documentation (methods & standards, test reports, clinical data, risk analysis). A well-structured GSPR checklist is the backbone of the TD and one of the first things a Notified Body reviews.
How is a technical documentation structured under MDR / IVDR?
MDR / IVDR Annex II defines the structure: device description and specification (including variants and accessories), information supplied by the manufacturer (labelling, IFU), design and manufacturing information, GSPRs, benefit-risk analysis and risk management, product verification and validation, and the clinical evaluation / performance evaluation. Annex III adds the post-market surveillance documentation. The key challenge is cross-referencing: every claim in the GSPR checklist must trace to specific evidence elsewhere in the file. We structure the TD to make these linkages clear and auditable.
Can you manage both EU and international registrations from one technical documentation?
Yes. The EU technical documentation under MDR / IVDR is typically the most comprehensive regulatory file for a device. We use it as the core and adapt it for other markets. For FDA 510(k), this means extracting and reformatting the relevant performance data, preparing the predicate device comparison, and building the substantial equivalence argumentation. For Health Canada, TGA, or NMPA, the adaptations differ. We coordinate international registrations through regulanet® for markets outside our direct presence.
What is the current status of EUDAMED and UDI obligations?
EUDAMED is being rolled out in phases. Under Regulation (EU) 2024/1860, the UDI/device registration module becomes mandatory from 28 May 2026. Actor registration and SRN (Single Registration Number) assignment are already required. We manage the registration process and UDI assignment. For manufacturers already holding certificates, we coordinate the transition to full EUDAMED compliance within the regulatory timelines.
How do you handle the IVDR transition for legacy IVDs?
Legacy IVDs that were previously self-certified or certified under IVDD now face reclassification under IVDR's risk-based framework (Class A through D), with most commercially significant products moving up in classification. We assess each product against the IVDR requirements, identify gaps (particularly in performance evaluation and clinical evidence), develop a prioritised transition plan, and manage the Notified Body submissions. The extended transition deadlines under Regulation (EU) 2024/1860 provide some relief, but the work must start well before the deadlines to avoid supply disruption.
What happens after CE marking?
CE marking is the starting point for post-market obligations, not the finish. Technical documentation must be maintained and updated for design changes, PMS findings, and regulatory changes. Notified Body re-certification audits occur annually (surveillance) and at certificate renewal. EUDAMED and UDI records must be kept current. For all post-CE marking activities, see Post-Approval & Lifecycle Management.