Medical devices EU market access – MDR/IVDR Compliance Support

Freyr Solutions simplifies compliances with EU requirements for medical devices under MDR (EU 2017/745) and IVDR (EU 2017/746) by guiding manufacturers through Notified Body conformity assessment, CE technical documentation, and EUDAMED registration, Gap analysis, transition from MDD to MDR, IVDD to IVDR, labeling & artwork compliance with EU requirements. As an experienced Regulatory partner, we support EU Authorised Representative (EAR) services, manage CE certification process, and ensure full post-market compliance.
With Freyr, you get CE marking, post-market surveillance, and audit-ready documentation so your team can focus on product innovation while we ensure regulatory precision.

Compliance for Medical device registration & regulation Landscape in EU

The European Union represents one of the most highly regulated and commercially attractive medical device markets in the world. Together with 27 member states, 3 EEA countries and Turkey, union market is operating under a harmonised Regulatory ecosystem defined by EU MDR (2017/745) for medical devices and EU IVDR (2017/746) for in vitro diagnostics, the region ensures uniform safety and performance standards across all product categories. To legally place a device on the EU Union market, manufacturers must obtain CE marking, which confirms compliance with the applicable regulation based on the device’s risk classification and conformity assessment route. Failure to meet these requirements can result in serious consequences, including product recall, seizure at customs, suspension of certification, or complete loss of market access.

Under the current Regulatory regime:

CE marking is mandatory for all medical devices and IVDs before they can be commercialised.
EUDAMED device registration is being introduced in phases, and several modules are already active for mandatory use.
Appointment of a European Authorised Representative (EAR) is obligatory for any manufacturer located outside the EU/EEA/Turkey.
Stricter MDR/IVDR classification rules demand robust technical documentation, clinical or performance evidence, and continuous lifecycle monitoring.

Freyr supports manufacturers throughout this journey by enabling smooth and compliant entry into the Union market. From developing a CE marking strategy and compiling technical documentation to managing Notified Body submissions and acting as your EU Authorized Representative, Freyr ensures fully aligned MDR/IVDR compliance and seamless access to all EU member states, EEA regions and Turkey.

Step-by-Step EU Compliance Process

Market access of a medical device &IVD in the EU/Union market involves several defined stages. Here’s how Freyr manages the entire process for you:

Typical processing time: 3–12 months, depending on device class and documentation readiness.

Freyr Medical Device EU Key Offerings

Regulatory Strategy & MDR/IVDR Transition – We craft end-to-end regulatory roadmaps tailored for the EU MDR and EU IVDR, ensuring smooth migration from Directive regimes and alignment with current EU requirements.
Technical Documentation & Conformity Assessment – Our team supports the development, review and submission of your Technical Files / Design Dossiers, assists with Notified Body engagements, and manages CE-Marking , device safety & performance test support and conformity pathways.
Clinical/Performance Evaluation : Freyr provides expert preparation of CERs, PERs, PMCF/PMPF plans, PSURs, SVR, CPR for IVDs ,risk documentation, and biological evaluation content, ensuring technical clarity and regulatory accuracy across all device classes.
UDI & EUDAMED Registration Support – We ensure your Unique Device Identification (UDI) system is compliant and assist with registration in the European device database EUDAMED and associated lifecycle management.
European Authorized Representative (EAR) & Local Representation – For manufacturers outside the EU/EEA/Turkey, we act as your mandated European Authorized ReprThis aesentative (EAR) and provide local compliance support across EU member states.
Post-Market Surveillance (PMS)– Freyr supports you to establish, implement and maintain PMS systems including Post-Market Surveillance Plan (PMSP), Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-Market Clinical/Performance Follow-Up plans (PMCF/PMPF), vigilance reporting, FSCAs, FSNs, CAPAs ensuring continuous CE-mark retention and sustainable market access with product lifecycle compliance.
CE Device Registration:Freyr manages the complete EU CE-marking registration pathway by supporting conformity assessment, compiling compliant submissions, engaging with Notified Bodies, and ensuring timely approvals across all medical device and IVD categories.
QMS Support:We support the implementation and maintenance of ISO 13485-compliant Quality Management Systems, aligned with the EU MDR/IVDR Quality and Safety requirements and Notified Body expectations.
Labeling Compliance:Our team ensures your labeling, IFUs, packaging, and symbols meet MDR/IVDR and EU multilingual language requirements, maintaining consistency and compliance across 27 EU member states.

EU Authorized Representative (EAR) Service Offerings

Device Registration with EU Authorities

For non-EU manufacturers, Freyr serves as the appointed EU Authorized Representative (EAR) in accordance with MDR/IVDR requirements. As a Germany-based entity, Freyr supports device registration activities with the relevant German Competent Authority and maintains required regulatory records. For other EU Member States, Freyr provides regulatory support, as applicable, to help ensure device compliance and facilitate placement of the device on the Union market.

Documentation & Conformity Assurance

Our regulatory experts verify that your Declaration of Conformity (DoC), CE Certificates, Technical Files are complete, current, and compliant with MDR/IVDR. Freyr ensures full readiness for conformity assessment and CE marking submissions.

Responding to Competent Authority Queries

If required Freyr handles all direct communication and clarification requests from EU Competent Authorities or Notified Bodies on your behalf, ensuring timely, accurate responses and helping prevent delays to approvals or post-market regulatory reviews.

Vigilance & Incident Communication

As your EAR, Freyr acts as the primary liaison for safety-related communications. If and when required, we coordinate incident notifications, Field Safety Corrective Actions (FSCA), and vigilance reporting between the manufacturer, healthcare professionals, and authorities to ensure proper response and regulatory alignment.

Inspection & Audit Readiness

Freyr maintains all documentation, correspondence, and mandatory records for authority audits and inspections. Our team ensures that Technical Documentation, labeling and post-market records are readily available and fully compliant with MDR/IVDR expectations.

Why Partner with Freyr?

End-to-end regulatory expertise that spans from pre-market registration to post-market vigilance, managing every stage of compliance.
A proven track record with 2000+ device registrations completed successfully across diverse categories.
Strong EU presence anchored in Germany (EAR), complemented by on-ground regulatory specialists in Reading and supported by Freyr’s global delivery teams.
Tailored transition planning that provides strategic support to obtain CE smoothly and cost-effectively.
Multi-region delivery teams with on-ground support through Freyr’s Germany-based EU operations.
Proven track record in MDR/IVDR remediation and legacy device transition
Transparent project governance with direct Notified Body communication

Celebrating Customers Success

Medical Devices

Registration and LR Support

Global

Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.

Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company

Medical Devices

Swiss Rep Services

Japan and Switzerland

I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.

Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company

Medical Devices

Registration and AR Services

Malaysia and Indonesia

Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.

Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

Frequently Asked Questions

What is What regulations govern medical device registration in the EU?

Medical devices in the EU must comply with MDR (EU 2017/745) and IVDR (EU 2017/746) to receive CE marking. These regulations mandate safety, performance, clinical evidence, technical documentation, and post-market surveillance requirements for all medical devices and IVDs.

How are medical devices and IVDs classified in the EU?

Devices are classified based on risk and intended use. MDR (Medical Devices): Class I, IIa, IIb, III, and IVDR (IVDs): Class A, B, C, D.Higher-risk classifications require Notified Body assessment, more documentation, and longer review timelines.

What documentation is required for CE marking?

Manufacturers must compile a Technical File / Design Dossier that includes device description, clinical/performance evidence, risk management, labeling, PMS/PMCF plans, and ISO 13485 QMS compliance. For higher-risk devices, Notified Body review is mandatory.

Are CE-marked devices accepted across all EU countries?

Yes. CE marking allows free market access across all 27 EU member states, and in most cases the EEA region, provided national language and labeling requirements are met.

How long does EU medical device approval take?

Timelines vary depending on the device class, documentation quality, and Notified Body capacity. Approvals typically range from 6 to 12 months, and may be longer for high-risk devices requiring extensive clinical evidence.

What are post-market responsibilities after CE marking?

Manufacturers must maintain PMS, PMCF/PMPF, vigilance reporting, PSUR submissions, and keep technical documentation continuously updated. These activities are essential to retain CE certification and market access.

Do non-EU manufacturers need local representation?

Yes. Companies without a legal presence in the EU must appoint a European Authorized Representative (EU AR) to communicate with Competent Authorities, manage vigilance notifications, and maintain compliance documents.

What challenges do manufacturers commonly face in EU registration?

Common challenges include technical documentation gaps, Notified Body delays, MDR/IVDR transition planning, and managing multilingual labeling and PMS. Most delays result from incomplete submissions or unclear CE strategy.

Why choose Freyr for EU medical device registration?

Freyr provides end-to-end CE marking support, including classification, Technical File preparation, Notified Body coordination, EUDAMED/UDI registration, PMS/PMCF execution, and EU Authorized Representative services. With strong MDR/IVDR expertise and proven delivery experience, Freyr reduces approval timelines, simplifies compliance, and ensures sustainable EU market access.