Expert services for drug-device combination products in the EU – Regulatory, CMC and clinical support
In the EU, drug–device combination products (DDCs) refer to cases in which a medicinal product and a medical device are combined or used together. The applicable regulatory framework depends on how the drug and device interact, with different requirements applying to integral combinations, ancillary medicinal substances, co‑packaged products, and devices intended for use with medicinal products.
Bringing drug–device combination products to market, and keeping them compliant throughout their lifecycle, requires an in‐depth understanding of both pharmaceutical and medical device regulatory frameworks, as well as their critical interfaces.
Medfiles supports clients with drug–device combination products from early regulatory strategy and product classification through development, writing marketing authorisation or CE-marking documentation, registration and post‑market compliance. Our multidisciplinary experts understand how medicinal product, medical device, regulatory affairs, CMC, clinical and pharmacovigilance requirements interact and how to turn this complexity into practical and efficient regulatory compliant solutions.
What is considered a drug–device combination product in the EU?
Combinations of medicinal products and medical devices are common in healthcare. In contrast to some other regions, the EU does not recognise “combination products” as a standalone regulatory category. Instead, such products are regulated under existing EU medicinal product and medical device frameworks, with the applicable regulatory pathway determined on a case‑by‑case basis.
This determination is based on factors including:
- the principal intended action of the product
- the intended purpose
- how the product is presented and used.
Drug–device combination products refer to medicinal products used together with a medical device, or products that incorporate both medicine and device, therefore triggering regulatory requirements under both EU medicinal product and medical device legislation.
The applicable documentation requirements and regulatory steps are directly influenced by the type of product and the way in which the medical device is integrated. Already at the clinical phase, this determines the approval pathway for clinical activities, which may follow a medicinal product-led process, a medical device-led process, or a coordinated parallel approach.
Regulatory and clinical services for DDC products throughout the product lifecycle
REGULATORY STRATEGY AND PRODUCT CLASSIFICATION
When the regulatory pathway for a drug–device combination product is unclear, early decisions can determine the course of development. Medfiles supports drug–device combination products with clear, science-based regulatory strategies and product classification, ensuring the most appropriate regulatory pathway is selected from the outset. We assess the product’s principal intended action, applicable EU legislation and regulatory options, helping to avoid delays, reduce regulatory risk and support efficient development and conformity assessment.
Our services include:
- EU regulatory strategy for drug–device combination products
- Support for determining the applicable product classification under EU Medical Device Regulation (MDR) and medicinal product legislation
- Borderline, combination and integral product assessments
- Assessment of regulatory implications related to MDR Article 117 and notified body involvement, where applicable
- Early interaction and positioning with competent authorities and notified bodies (NBs)
- Clinical research strategy support for device-lead or drug-lead combination products
- Clinical evaluation and clinical evidence planning.
Our regulatory strategy work is closely integrated with downstream development, clinical and post-market activities, ensuring consistency throughout the product lifecycle.
Development, documentation and regulatory alignment
Drug–device combination products require careful alignment between the medicinal product and the device, both in design and in documentation. We support drug–device combination products with development and documentation services that ensure technical, CMC and regulatory alignment across the medicinal product–device interface.
Our services include:
- Interface documentation between the medicinal product and the device
- Technical documentation support and regulatory alignment across frameworks
- Support for design and development documentation at the drug–device interface
- Risk management and usability considerations for combination products
- Alignment of quality management system (QMS) documentation
Clinical services for drug-device combination products
Medfiles provides clinical services for drug–device combination products, supporting both clinical trials for drug-led combination products and clinical investigations for device-led medical devices. We ensure that clinical strategies and evidence generation are aligned across both regulatory frameworks once combination products are studied.
Our clinical services include:
- Clinical development and evaluation strategy for drug–device combination products
- Coordination of clinical trials and clinical investigations, from study planning to final reporting
- Medical writing and regulatory support for planning phase and reporting
- Submissions and registrations, including coordination with competent authorities and ethics committees and assistance with CTIS portal and EUDAMED
- Coordination and liaison with competent authorities and ethics committee
- CMC documentation for clinical trial application documentation (IMPD) for drug-led combinations
- Set-up and maintenance of study related documentation including trial master file (eTMF) and project plans, risk management plans, monitoring plans as per EU MDR for device-led combinations
- Monitoring of clinical trials or investigations and site oversight
- Clinical safety
- Preparation of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and Clinical Development Plans
- Planning of post-market clinical follow-up (PMCF) strategies
Pharmaceutical Chemical (CMC) expert services and CMC consulting
Medfiles supports you with CMC consulting and documentation services that align with current regulatory expectations. Our team of experts provides consulting throughout product development, preparing CMC documentation for marketing authorisations of drug-led DDCs that help to avoid unnecessary delays and ensuring submission readiness. Medfiles’ CMC expertise combines deep industry knowledge with regulatory insight, built through years of experience with both pharmaceutical companies and authorities.
Our CMC services cover the following areas:
- Documentation for Module 3
- Quality overall summaries
- Responses for requests for additional information during marketing authorisation procedures
- Evaluation of dossiers (gap analysis)
- Active substance documentation (ASMF, DMF and CEP)
- Validation plans and reports
- Risk assessments (nitrosamines, elemental impurities)
- Outsourced experts for your projects – for both manufacturing processes and analytics
Regulatory submissions and approvals
Bringing a drug–device combination product to the EU market often involves parallel regulatory processes and coordinated interactions with authorities and notified bodies. Medfiles supports regulatory submissions and authority interactions across the EU, covering both medicinal product and medical device pathways, as well as their interface in drug–device combination products.
Our services include:
- Support for medicinal product dossier and marketing authorisation procedures
- Conformity assessment support under EU MDR
- Coordination between notified bodies and competent authorities
- Support for MDR Article 117 requirements and notified body opinions
- Preparation, submission and management of marketing authorisation applications and responses during authority review
Our experienced Regulatory Affairs experts support complex submissions and authority interactions across the EU.
Pharmacovigilance and Post-Market Surveillance (PMS)
Ensuring the safety of drug–device combination products requires continuous oversight across both medicinal product and medical device requirements. Medfiles provides safety and post-market support across the full lifecycle, from first-in-human studies through to post-marketing activities, ensuring that pharmacovigilance and post-market requirements are implemented in a compliant and efficient manner.
Our pharmacovigilance services include:
- Safety system set-up and management
- Clinical trial safety (SAE/SUSAR processing, medical review, expedited reporting)
- Post-marketing safety case processing and reporting
- Signal detection and benefit–risk assessment
- Risk management plan (RMP) development and maintenance
- Aggregate reporting (DSURs, PSURs/PBRERs)
- Literature screening and safety monitoring
- Post-market surveillance (PMS) and vigilance activities
- Implementation of post-market clinical follow-up (PMCF) activities
- Quality system implementation and maintenance supporting pharmacovigilance and post-market activities
- QPPV services, PSMF maintenance and inspection readiness
- PV audits, SOP development, training and vendor oversight
Lifecycle management
After approval, drug–device combination products continue to evolve through changes and ongoing regulatory requirements. Medfiles supports lifecycle management by ensuring regulatory compliance and continuity throughout product updates, variations and maintenance activities.
Our services include:
- Support for variations, changes and extensions
- Regulatory maintenance across the product lifecycle
- Support for labelling and marketing materials including translations
- CMC support for variations, including documentation updates (Module 3 and 2.3)
- Consultation on studies required to support a change
- Coordination of regulatory, clinical, safety and quality requirements during lifecycle changes
Why Work with Medfiles on Drug-Device Combination Products?
With Medfiles, you get practical support for drug–device combination products – from targeted input to fully outsourced solutions. We help you plan, prepare and manage regulatory activities so that requirements and timelines are met.
- Strong experience on EU regulatory requirements, including clinical trials/investigations, approval and lifecycle management
- Practical, authority-ready documentation and processes for companies of all sizes
- Combined expertise in medicinal products and medical devices
Our services are flexible and tailored to each client’s needs. We can:
- support with specific, clearly defined tasks
- act as a regulatory, CMC and clinical sparring partner for complex interface questions
- provide fully outsourced regulatory, CMC, clinical and pharmacovigilance services for long-term collaboration
Extensive experience within the EU
30+
YEARS OF EXPERIENCE IN CLINICAL TRIALS AND REGULATORY AFFAIRS FOR MEDICINES
20+
YEARS OF EXPERIENCE IN PHARMACOVIGILANCE
15+
YEARS OF EXPERIENCE IN REGULATORY AFFAIRS FOR MEDICAL DEVICES AND IVDS
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