News

Obelis Group & QUNIQUE form Strategic Partnership

Brussels, Belgium, November 3rd, 2020, Today Obelis and QUNIQUE announced a strategic partnership to exchange expertise and knowledge in the field of the MDR & IVDR, enabling medical device manufacturers to safely transition and become compliant with the new medical device legislation. Expanded Partnership with Continued Focus on Customer Value

EC publishes preliminary opinion on electronic cigarettes

SCHEER 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). It is worth pointing out that any e-liquid which does not contain nicotine will be subject instead to the rules set

Swiss Medtech calls for the update of the Mutual Recognition Agreement with the EU

In the referendum that was held on September 27, 2020, the Swiss population and cantons rejected ‘’the limitation initiative’’, which demonstrates the public’s approval of their bilateral path with the EU. In view of the Medical Device Regulation (MDR) becoming fully applicable in the EU next May 26, 2021,

COVID-19 antibody ‘’self-tests” no longer banned in Belgium

In the context of the global pandemic, the Belgian Competent Authority FAMHP decided not to prolong the ban on the usage of ‘’at-home tests’’ - detecting antibodies against the new coronavirus (SARS-CoV-2) - that was in place since March 2020. The FAMHP expects prompt availability of compliant ‘’at-home tests’’, it

Safety of prostaglandins in cosmetics: Call for scientific data

The European Commission invites interested parties to submit relevant data on the use of prostaglandins and their analogues in cosmetic products within the consultation period that ends on October 22, 2020. Reasoning The European Commission has received several notifications of serious undesirable effects caused by the use of cosmetic products

MDR: Common specifications for reprocessing of single-use devices

The MDR (Regulation (EU) 2017/745) allows reprocessing of single-use devices only where it is permitted by national law. In fact, when reprocessed and used within a health institution, the MDR allows Member States not to apply all the rules relating to manufacturers’ obligations laid down in that Regulation (Article

Medical device procurement in Vietnam: How many Free Sales Certificates do you need?

In July 2020, the Vietnamese Ministry of Health published a circular concerning the new procedure for medical device tenders in public health facilities. This circular, entering into force on the 1st of September 2020, covers different aspects of the bidding process and introduces a new classification for medical device bidding

New Motor Vehicle Regulation 2018/858 – Fully applicable from September 1, 2020

After the two-year transitional period, on September 1, 2020, the new Motor Vehicle Regulation 2018/858 will become fully applicable and repeal the Motor Vehicle Directive (MVD). Just like the MVD, the MVR is based on the Whole Vehicle Type-Approval System (EU WVTA). It applies to motor vehicles of categories

Lilial classified as a CMR substance

On August 11, 2020, the European Commission published in the Official Journal of the EU a Delegated Regulation amending the Classification, Labelling and Packaging Regulation (CLP Regulation). The change concerns several ingredients, which were classified as CMR substances, and notably the allergen Buthylphenyl Methylpropional, also known as BMHCA or Lilial.

Radio Equipment Directive - Obligations associated with the placing on the market

Recently, the European Commission’s Group of Administrative Co-operation Under the Radio Equipment Directive 2014/53/EU has issued the Information sheet on obligations associated with the placing on of radio equipment on the market. The sheet is a non-binding act that lays down the administrative requirements for placing equipment

MedTech Europe raises industry concerns over the successful transition to the new IVDR

MedTech Europe, the European trade association which represents the medical technology industry, has published on July 9 a position paper voicing the growing concerns of the industry on the halted progress in the implementation of the Regulation (EU) IVDR 2017/746 (In-vitro Diagnostic Medical Device Regulation - IVDR). With the