Medical devices · Cosmetics
Your regulatory path to the European Union.
Medical devices follow the MDR and cosmetics the EU Cosmetics Regulation. We prepare your files and act as your EU Authorized Representative or Responsible Person.
Medical devices · Cosmetics · ISO 9001 certified in Brazil · Service in PT · EN · DE
WHERE YOU ARE COMING FROM
Two starting points, one market
First time in the EU
You are outside the European Union and want to place your device or cosmetic on the EU market.
- Your MDR class and conformity route defined
- Technical documentation ready for notified body review, where required
- Sobel as your EU Authorized Representative or Responsible Person
Already approved in another market
Your product is already on the market in Brazil or the U.S. and Europe is your next step.
- What can be reused from your ANVISA or FDA file
- Gaps against the MDR safety and performance requirements
- Cosmetics: CPSR, product information file and EU labels
What are you bringing to the EU?
Each product follows its own EU rules. Pick yours for the full path.
Medical Devices
Equipment, implants and software, from classification to CE marking.
SERVICES IN THE EUROPEAN UNION
Everything we do for the EU market
Documentation, evidence and representation in Europe, in one team.
Strategy and MDR classification
Device class, conformity route and timeline.
Technical documentation and CE marking
MDR technical file and support with your notified body.
Quality system (ISO 13485)
QMS aligned with the MDR, plus internal audits.
Biological and clinical evaluation
ISO 10993 and your clinical evaluation report (CER).
CPSR and product information file
Safety report signed by a qualified safety assessor.
CPNP notification and labelling
Notification in the EU portal and label review.
EU representation
Authorized Representative for devices, Responsible Person for cosmetics.
Ongoing support
Monthly support for changes, renewals and EU updates.
Why Sobel
Regulation as a business decision, not a checklist.
Four disciplines work on every project, in the same team, from the first decision to post-market.
Strategy
Classification and market sequence decided first. The right class from day one avoids rework.
Science in house
Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.
Regulatory, five markets
ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.
Technology
A dedicated technology team builds the workflows that keep every project traceable and on time.
“We know how auditors think, because we’ve been one of them.”
Maik Endler
Founder & CEO
- Mechanical engineer, trained in Germany
- Former BSI auditor (Notified Body)
- Industry experience at Sirona (now Dentsply Sirona)
FAQ · EUROPEAN UNION
What companies ask before entering the EU
Short answers for medical devices and cosmetics. Each product page goes into the details.
Ask your question →Which rules apply to medical devices and cosmetics in the EU?
Medical devices follow Regulation (EU) 2017/745 (MDR) and cosmetics follow Regulation (EC) No 1223/2009. Both apply directly in every EU member state.
Do I need a representative in the EU?
Yes. Device manufacturers established outside the EU must designate an Authorized Representative (MDR, Article 11). Each cosmetic needs a Responsible Person established in the EU (Regulation 1223/2009, Article 4). Sobel offers both services. Learn about the Authorized Representative service.
Does my device need a notified body?
It depends on the class. Most Class I devices are self-declared by the manufacturer. Class I devices that are sterile, have a measuring function or are reusable surgical instruments, and all Class IIa, IIb and III devices, need a notified body.
What does a cosmetic need before going on sale in the EU?
A Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor, a product information file kept by the Responsible Person, notification in the CPNP and labels that meet the Regulation.
