On November 3rd, 2020, Obelis and QUNIQUE announced a strategic partnership to exchange expertise and knowledge in the field of the MDR & IVDR
News
Mutual Recognition: making it easier to sell in multiple EU countries
Manufacturers may certainly benefit from mutual recognition by the Regulation 2019/515/EU, which replacing the previously applicable Regulation 764/2008/EC
EC publishes preliminary opinion on electronic cigarettes
Electronic cigarettes and any e-liquid containing nicotine are subject to the discipline set out by the Tobacco Products Directive 2014/40/EU (TPD).
General Data Protection – Compliance Process
Expert guidance on the compliance process for the processing of personal data in the European Union according to the GDPR Regulation. Learn more here.
Swiss Medtech calls for the update of the Mutual Recognition Agreement with the EU
With MDR quickly approaching, the Swiss Medtech urges for solution to eliminate technical barriers to trade medical devices in the EU. Read more here!
Brexit, what about UK-EU Trade?
The UK tax authority HMRC sent to businesses in GB a letter on how to prepare for new processes for moving goods between UK and EU from 01/01/21. Read more here!
Safety of prostaglandins in cosmetics: Call for scientific data
The EU Commission invites parties to submit relevant data on the use of prostaglandins and their analogues in cosmetic products. Read more details here!
MDR: Common specifications for reprocessing of single-use devices
Common specifications for reprocessing single-use medical devices in Europe under EU medical device regulation 2017/745.
Medical device procurement in Vietnam: How many Free Sales Certificates do you need?
Learn more about the new procedures for medical device procurement in Vietnamese public health facilities and free sales certificate requirements and limits.
New Motor Vehicle Regulation 2018/858 – Fully applicable from September 1, 2020
European Motor Vehicle Regulation 2018/858 entered full effect in September 2020. Talk to our EU regulatory experts about your vehicle or product's compliance.