News

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

Simplification of conformity procedures for CoViD-19 Pandemic-relevant products in Portugal

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,

Joint effort for more knowledge on endocrine disruptors

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

Faster access of IVDs on the French market

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

AEMPS Information about market campaign control for sunscreen products

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

National MDR implementation – Germany’s establishment of NAKI

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

Guidance for placing hand sanitizing products on the UK market

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

MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

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