The Global Medical Device Market. A Multi-Billion Opportunity.

European Union (EU): 

The second-largest medtech market (~€160 billion). CE marking under MDR ensures access to 27 countries, but the new regulations make approvals complex and time-consuming.

United Kingdom (UK): 

The UK’s medtech sector is valued at $18 billion, expected to double by 2032. Post-Brexit, new rules require UKCA marking & a UK Responsible Person.

United States: 

The world’s largest market, valued at $184 billion in 2024, projected to hit $311 billion by 2033!  However, FDA compliance hurdles slow down approvals, requiring expert guidance.

Our Regulatory Services

Full Compliance Without the Headache

We help you with:

• Complying with EU MDR/IVDR regulations
• EUDAMED registration (actor & device)
• Technical documentation review
• Post-market surveillance support
• Official legal representation for non-EU manufacturers

European Authorized Representative (EU AR)

Switzerland: 

A high-value €23 billion market, yet since 2021, the lack of an EU-Swiss agreement means a Swiss Authorized Representative is now mandatory.

Client Success  stories.

 Want to expand into these markets hassle-free? 

We’ll handle compliance while you focus on selling your product.

Pain Points Solved:

• Notified Body delays (MDR slow approvals!)
• New clinical evidence & safety reporting requirements
• Heavier post-market obligations & high documentation costs

We help you with:

• MHRA registration & UK device compliance
• UKCA marking guidance & transition planning
• Ongoing legal representation in the UK
• Technical file maintenance & safety reporting

UK Responsible Person (UK RP)

Pain Points Solved:

• UKCA transition uncertainty – We ensure a smooth shift before 2030!
• Mandatory UKRP requirement for non-UK companies
• Additional UK regulations separate from EU MDR

We help you with:

• FDA Establishment Registration & Device Listing
• 510(k), PMA, De Novo, & HDE submission support
• Legal US representation for foreign manufacturers
• Quality compliance with FDA & ISO 13485 standards

US Agent & FDA Official Correspondent

Pain Points Solved:

• FDA approval delays – 163+ days for 510(k) & 1,000+ days for PMA!
• Complex compliance with new Quality System rules
• Mandatory US agent requirement for non-US companies

We help you with:

• Swissmedic registration & device notification
• Local regulatory representation in Switzerland
• Technical file verification
• Legal compliance for Swiss importation

Swiss Authorized Representative (CH RP)

Pain Points Solved:

• No more free access between EU & Switzerland-Swiss CH-REP is now a must!
• Extra device registration required in Switzerland
• Regulatory duplication with EU MDR rules

 CE marking under MDR means endless documentation, but don’t worry, we handle it all for you!

Climbing the Alps is a challenge. Swiss compliance shouldn’t be. 

We’ve got you covered!

 Post-Brexit compliance is a maze. We navigate UKCA, MHRA, and UKRP requirements for you.

 FDA approvals are complex and slow, but with the right strategy, we’ll speed up your market entry.

I encourage companies to seek compliance before putting their products on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.​

 We successfully launched our products into multiple European countries.

Ran Amos

VP of Quality Assurance & Regulatory Affairs

We were under huge time and cost pressure for a new OEM product line launch and we relied on Obelis. It was the right decision, their expert team helped us to avoid possible regulatory complications.

Their expert team helped us to avoid possible regulatory complications

Florian L. Gablenz 

Business Development Manager 

We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make it seem so easy.

 We feel very supported!

Javier Aravena

Regulatory Affairs Manager

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