Alongside ten national market surveillance authorities,62 devices were tested in compliance with the administrative and technical requirements of the EMC Directive 2014/30/EU. Read all the results that the campaign has provided in our article!
Market surveillance and compliance
Shaping the future of the EU market. The legislative framework for industrial products under revision
In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy. Read more
Marine Equipment Directive: Market Surveillance discussions
In November 2021, ADCO MED published an information document on Directive 2019/90/EU. The document collects answers on various topics discussed by the Member States market surveillance authorities and the European Commission. We summarize it in this article!
IVDR: What are EU Reference Laboratories (EURLs)?
With the In Vitro Diagnostic Medical Devices Regulation (IVDR), the IVD sector in the European Union is about to experience significant changes. From a new classification system to stricter assessment procedures and market surveillance. Read the full article to discover all the details!
IVDR: Clinical Evidence Requirements for Manufacturers
Article 56 (1) of the Regulation on in vitro diagnostic medical devices states that manufacturers must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose. Read all the details!
HPRA 2020 Annual Report
Each year, Health Products Regulatory Authority (HPRA) publishes the annual report outlining its activities in the area of public and animals’ health. The Irish agency’s new report was published on November 20, 2021, and summarises last year’s programs development to regulate health products and the safety of cosmetics. Read the full article to know more!
«A new industrial strategy for Europe» an update
The Industrial Forum was created in 2021 to assist the Commission in implementing the 2020 «new industrial strategy for Europe». On the 2nd of December 2021, the Forum’s third meeting took place! Read the full article to discover the latest update about it.
New cybersecurity obligations under Radio Equipment Directive (RED)
On October 29, 2021, the European Commission adopted a delegated act to the Radio Equipment Directive aiming at scaling up the cybersecurity of wireless devices and products for the benefit of consumers. Want to know more? Visit our page!
Requirements for Legacy Devices under the MDR as of May 26, 2021
In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.
Regulation on General Product Safety: towards stronger consumer product safety
On June 30, 2021, the European Commission published a Proposal for the General Product Safety Regulation. For more details visit our page!