Are you a manufacturer of medical devices based outside the European Union? If your products are heading for the EU market, full compliance with Regulation (EU) 2017/745 (MDR) is not an option — it is a legal obligation. At ASC Services, we specialize in guiding non-EU manufacturers through the complex requirements of the MDR, offering full regulatory assistance to ensure smooth, efficient and compliant market access.
The Challenges of MDR Compliance
Since its full application in May 2021, the Medical Device Regulation (MDR) has radically transformed the European regulatory landscape. Unlike the previous MDD framework, the MDR introduces:
- Stricter classification rules
- Enhanced clinical evaluation requirements
- Stronger post-market surveillance obligations
- UDI system and EUDAMED registration
- Increased documentation, including the Technical File and Declaration of Conformity
For manufacturers based in the United States, Asia, South America or the Middle East, this represents a significant challenge: navigating a foreign regulatory framework, in a different language, with high expectations in terms of traceability, safety, and documentation.
This is where ASC Services comes in.
A Full-Service EU Regulatory Partner
We are a European consultancy specialized in medical device regulatory compliance under MDR and IVDR. Our services cover every step of the journey — from regulatory strategy to post-market compliance. Specifically for non-EU manufacturers, we offer:
1. Authorized Representative (EC-REP)
As your European Authorized Representative, ASC Services will:
- Register your company and products in EUDAMED
- Maintain a single point of contact with EU Competent Authorities
- Store and update your Technical Documentation
- Monitor regulatory changes and safety alerts
- Provide immediate support in case of incidents or inspections
We hold full liability under Article 11 of the MDR, giving your clients and distributors peace of mind.
2. Technical File Audit and Gap Analysis
Avoid costly delays and Notified Body rejections by ensuring your technical file is MDR-compliant. We review and support the preparation of:
- Clinical Evaluation Reports (CER)
- Risk Management Files (ISO 14971)
- PMS and PMCF Plans
- Labeling and IFU (Instructions for Use) in line with MDR Annex I
- UDI-DI registration and Basic UDI-DI assignment
Our team can also validate software documentation for Medical Device Software (MDSW) and help ensure cybersecurity and AI integration meet EU standards.
3. Importer & Distributor Regulatory Training
If your products are already in the EU supply chain, ASC can train and audit your local importers and distributors to ensure they meet their Article 13 and 14 obligations under MDR.
We also offer customized SOPs and compliance documentation packs for your supply chain partners.
EUDAMED Registration Support: Modules and SRN
The European EUDAMED database is being progressively implemented, and the Actor Registration module is now mandatory. ASC Services helps you:
- Apply for your Single Registration Number (SRN)
- Understand the different EUDAMED modules (actor, UDI, certificate, vigilance, clinical)
- Register devices and upload documentation in line with MDR timelines
- Monitor deadlines and ensure full traceability
We work closely with EU Competent Authorities and Notified Bodies to ensure your data is accurate and your SRN is valid and active.
Why Choose ASC Services?
- Over 20 years of experience in the medical device sector
- Experts in MDR, ISO 13485, and EU regulatory systems
- Bilingual team (English-Spanish) with deep knowledge of EU procedures
- Strategic location in Spain, with access to EU-wide regulatory networks
- Transparent pricing and fast onboarding process
- Experience in Class I, IIa, IIb, and III devices, including aesthetic and diagnostic products
Our Clients: From Global Brands to Innovative Startups
We support a wide range of companies, from established multinational manufacturers to innovative MedTech startups entering the EU for the first time. Whether you need a full turnkey solution or specific regulatory support, our team will tailor the service to your needs.
Let’s Get Started
If you are a non-EU manufacturer planning to access the European market — or if you are already present but need to reinforce your regulatory presence — contact us today. ASC Services is your MDR compliance partner in the EU, offering peace of mind and operational efficiency.
📩 Contact: web@ascservices.es
🌍 Website: www.ascservices.es