Supporting you with ad-hoc legal matter
Do you want to have your trade mark 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?
Obelis can provide you with legal services to support your EU operations.
Conducting legal analysis of EU laws – Do you wish to understand more about a specific EU legislation, and under which circumstances it is applicable to you?
Obelis can perform a legal analysis on EU laws falling within our competences.
- Issuance of official statements – Throughout the course of your business activities you may need to present proof that you have registered/notified your products, that you have appointed an Authorised Representative or Responsible Person or that you have fulfilled certain obligations under the applicable legislation.
For these and other similar requests, Obelis can assist you by issuing an official statement, signed by our CEO.
- Review of agreements and provision of templates – The Medical Device Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) have expanded the obligations of manufacturers, importers and distributors and have underlined the need for strong cooperation between them. As such it is of high importance that there are quality agreements in place between all the economic operators involved in the supply chain. Obelis can review your existing agreements or provide you with templates through MDlaw, allowing for the smooth transitioning to the new laws.
- EU trade mark registration with the EU Intellectual Property Office (EUIPO) - Your trade mark is the symbol that your customers use to distinguish you from your competitor. To protect your trade mark, you can register it with the EU IPO, which will give you an EU-wide protection in all EU Member States. You can register for example a word, symbol or a combination of both, as a trade mark with the EU IPO.
Obelis can help you register your trade mark in the EU.
- Trade mark research and clearance – before applying for a trade mark registration on your behalf, Obelis will research whether there are similar, already registered trade marks in the EU IPO database. If there are and the degree of similarity is high, Obelis will advise you on the possibility to proceed or change your trade mark to ensure its uniqueness.
Assisting with General Data Protection Regulation (GDPR) matter
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 who are in the EU in the course of offering them goods or services or monitoring their behavior, then GDPR applies to you.
- Applicability assessment and consultancy – Obelis can help you with the assessment of whether the GDPR applies to you or not. If the GDPR is applicable, Obelis can guide you with the next steps for ensuring compliance.
- GDPR Representative services to manufacturers processing data of, among others, Belgian subjects – If the GDPR is applicable to your activities and you are established outside of the EU, you must have a GDPR Representative in the EU. Obelis can act as your GDPR Representative and act as your consultant on your data processing activities if you process data of Belgian subjects.