EU Consultancy, Legal & Training

EU Consultancy, Legal & Training

Understanding the EU Regulatory landscape with our Consultancy services

The EU Regulatory landscape can be difficult to navigate. In addition to a complex system, laws are updated frequently, and new regulations are replacing existing directives. Staying up to date and be prepared for changes is crucial for manufacturers to be compliant and avoid breaches.

For both EU and extra-EU manufacturers, we offer consultancy and training services to help you understand and apply the appropriate EU legislation. With over 30 years of experience, we have guided thousands of manufacturers from all over the world with our Regulatory expertise.

Among others, our Consultancy services include:

  • Regulatory support and advice
  • Ensure compliant technical documentation
  • Evaluate claims and labels
  • Compilation of documents
  • Regulatory research
  • Updates on regulatory matters
  • Translations

Your EU Consultant will help you:

  • Successfully penetrate the EU marketplace
  • Ensure compliant technical documentation
  • Conduct EU Research and Clinical Investigations
  • Evaluate EU Market Claims
  • EU Labeling & Translations
  • Remain up-to-date on legislative/economic/political matters that may influence your product compliance (i.e. Brexit)
  • Provide support in determining an effective overall EU Market Strategy (i.e. distribution, warehousing, etc)

Strengthening your Regulatory knowledge with our Trainings

To strengthen your knowledge on the EU Regulatory system, we offer trainings on a wide range of topics. We can guide you through various Regulatory matters with online or on-site trainings. Some of our strongest areas of expertise are medical devices and IVD medical devices, cosmetics, food supplements, aesthetic devices, electronics, industrial and mechanical sector, protective equipment, technology and innovation, consumer goods, and other.

From general insights to the most challenging aspects, a few of our consultancy areas on which we also propose trainings are:

  • European Authorized Representative, EU Responsible Person
  • Technical File Creation, Review
  • Product Registration, National Device Registration
  • Vigilance, Clinical Evidence, Clinical Evaluation Report, Risk Management
  • Product Classification
  • Free Sales Certificates (FSC)
  • Harmonised Standards
  • Navigating Obelis’ information platforms (MDlaw and COSlaw)

In addition to trainings, we offer various webinars held by our experts. On both Obelis website and Obelis’ information platforms, MDlaw and COSlaw, you can find a vast selection of webinars.

Obelis can provide you with further legal services to support your EU operations. Do you want to have your trademark protected for the whole EU territory or in the UK? Do you need a review of the quality agreement you have in place with your importer and distributor under the MDR or IVDR? Do you use the personal data of people in the EU and wish to know if the GDPR applies to you?

We can assist you with:

  • Conducting legal analysis of EU laws
  • Issuance of official statements
  • Review of agreements and provision of templates
  • EU trademark registration with the EU Intellectual Property Office (EUIPO)
  • Trademark research and clearance
  • Assistance with General Data Protection Regulation (GDPR) matters

Assisting with General Data Protection Regulation (GDPR) matters

If you are established in the EU and processing personal data anywhere in the world, or if you are not established in the EU but you are processing personal data for people in the EU, then GDPR applies to you.

  • Applicability assessment and consultancy,

Learn more about our services:

Read more about GDPR:

Interested in our GDPR services? Contact us and one of our experts will immediately be in touch with you!

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