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
As a response to the Covid-19 pandemic, and following the Commission’s Recommendation 2020/403, published in March, the Portuguese government has published legislation aimed at increasing the availability of Covid-19 pandemic-relevant products. In April, a decree-law established special and transitory rules to simplify and speed up the manufacture, import,
National authorities from Belgium, Denmark, France, the Netherlands, and Sweden have developed a database about endocrine disruptors (ED) in the European Union (EU) – Endocrine Disruptor Lists. Endocrine disruptors, which are likely to be found in everyday products (e.g. personal care products, toys, resins) have been increasingly linked to conditions
In the context of the health emergency in France due to the COVID-19 pandemic, a Decree was issued in order to ensure a bigger availability of COVID detection tests to the laboratories. Among the measures, a process of derogation from the usual conformity assessment route was adopted for SARS-CoV-2 RT-PCR
The Spanish Agency for Medicines and Health Products (AEMPS) started last December a market control campaign for sunscreen products, to guarantee that the sun protection factor (SPF) conforms to the one claimed in the labeling. Guaranteeing such products effectiveness is the main goal and this market control action complements the
What is the advice of the UK competent authorities for the manufacturers of 3D-printed devices or components? As one may deduce, different requirements apply for 3D-printed products, depending on their classification. It is not the same to be classified as a medical device or personal protective equipment (PPE) when it
The Spanish Agency of Medicines and Medical Device (AEMPS) has published guidance on labeling and safety instructions for the use and preservation of hydroalcoholic gels and solutions. Hydroalcoholic gels/solutions are classified as biocides or cosmetics depending on the primary function of the product, claims and the content of alcohol.
In 2017, Germany has established Nationaler Arbeitskreis (NAKI) - the National Working Group for the Implementation of the new EU Regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR). The group was created in order to set up a solid basis for the proper national implementation of new EU
Due to the COVID-19 crisis, production of surgical masks has significantly increased. Therefore, the Belgian Competent Authority FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks. Following the amendment to the ministerial decree of 23 March 2020 laying down specific measures within the framework of
In May 2020, the Office for Product Safety & Standards issued a guidance for the placement on the UK of hand cleaning and sanitising products. The demand for these type of products has risen, as a consequence of the COVID-19 pandemic, and it is common for manufacturers and importers to
The battle against COVID leads to regulatory changes. The UK, as well as many others, is trying to combat the virus with all its strength and, to do so, needs a non-stop chain of medical devices arriving to its coasts. To this end, the MHRA has accelerated the procedure for
The French National Agency for the Safety of Medicines and Health Products (ANSM) has supported the Directorate-General for Competition, Consumption and the Suppression of Fraud (DGCCRF) in the development of joint recommendations on the affixing of certain claims on cosmetic products. The recommendations focus on claims concerning the absence of
