Regardless the outcome of the ongoing EU trade negotiations, Brexit will imply certain consequences for economic actors. In particular, because even if a free trade agreement is concluded between the UK and the EU, the above does not provide for internal market concepts (in the area of goods and services)
The European Commission adopted a new measure to respond to the current COVID-19 outbreak. With the agreement of the European standardization committees (CEN/CENELEC), number of harmonised standards were made freely available to those companies that are willing to start producing essential protective equipment like face masks and single-use gloves,
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK Competent Authority, has updated its guidance on withdrawal of notified body services. After several notified bodies based in the UK withdrew their services in view of Brexit, many manufacturers feared that they might not be able to find a new
With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that
In February 2020, the Working Group on Cosmetic Products updated the Cosmetics Borderline Manual and included two new entries concerning nail care products and massage products, as well as a modification to the essential oils entry. The Manual is an important document as it presents (a collection) of best practices
The cosmetic ingredient Zinc Pyrithione (ZPT) is frequently used in the formulation of hair conditioners, shampoos, face powders, cleansing products, eyeliners and skin care products. On the 4th March 2020, the Scientific Committee on Consumer Safety concluded that Zinc Pyrithione is safe when used as an anti-dandruff in rinse-off hair
The latest news on the approval process of the UK Medical Device law As COVID-19 keeps troubling the world, Brexit negotiations appear to be on hold. In fact, EU trade talks could be postponed due to the coronavirus. Nevertheless, the new UK law on Medical Devices has lately been progressing
In the context of Covid-19 global outbreak, the European Commission (EC) published a Recommendation(EU) 2020/403 to the manufacturers, Notified Bodies and Competent Authorities on conformity assessment and market surveillance procedures to address the continuously increasing demand of PPE such as face masks, gloves, protective coveralls or eyewear protection
Ireland is one of the top five global medtech hubs and, in order to increase its role, the Irish Medtech Association that represents the medtech sector proposes two key priorities for the next government: Investing in InnovationInvest in PeopleIn particular, the MedTech Association outlines recommendations under three pillars [1]: PILLAR
In order to be able to CE mark medical devices, manufacturers have to provide clinical data on said devices. One of the ways to provide such data is to conduct a clinical investigation. In order to assist manufacturers on this matter, the UK Medicines and Health products Regulatory Agency (MHRA)
Cannabidiol and its rise in food supplements in the EU Cannabidiol (CBD) has been capturing more and more the attention of manufacturers and consumers in many different consumer products, particularly in food supplements in view of its multiple and alleged beneficial properties for human health. CBD is a non-psychoactive compound
The Irish Health Products Regulatory Authority (HPRA) has recently issued a brief explanation of the impact that Brexit will have upon medical devices during the transitional period, namely until December 31, 2020. The UK officially left the EU on January 31, 2020, after having reached an agreement with the EU
