The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) is adapting its organisational structure to help Europe’s industrial ecosystems recover more effectively from the COVID-crisis and to achieve the EU's digital and green goals.
The European Commission is calling for applications from stakeholder associations to select observers to the EUDAMED sub-group of the medical devices coordination group (MDCG).
The new lists of references of harmonised standards for medical devices have been published (OJ L 0901 of 25 May 2020). They can be found below.
In the context of the Coronavirus crisis, the Commission is working with industry and EU countries to maximise the availability of masks, gloves, gowns and other medical supplies. At the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment.
Since 1 February 2020, the UK has withdrawn from the EU. The ‘withdrawal agreement’ provides for a transition period ending on 31 December 2020. As of 1 January 2021, there will be broad and far-reaching consequences, regardless of the outcome of ongoing Brexit negotiations. Stakeholders must make sure they are ready for them.
This is an updated version of the call replacing the version published on 27/01/2020. Deadline for submission of applications is extended until 6 March 2020. To ensure the necessary technical input for the group of products mentioned in Annex XVI of Regulation (EU) 2017/745 on medical devices, the European Commission is calling for applications from stakeholder associations to select observers to the Annex XVI sub-group of the medical devices coordination group (MDCG).
This is a general forecast of upcoming meetings planned at the date of publication and will be regularly updated. Please note that meetings and dates will be confirmed by an official invitation to participants.
The European Commission published a call for expression of interest to appoint experts to scientific panels. The selected experts will need to provide consistent scientific, technical and/or clinical advice on the implementation of Regulation (EU) 2017/745 on medical devices.
In order to ensure the necessary technical input for the medical devices nomenclature, the Commission is calling for applications from stakeholder associations in order to select observers to the nomenclature sub-group of the medical devices coordination group (MDCG).
The European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation until 31 August 2019.
This is a call for data on the ingredients: Benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan, resorcinol, octocrylene, triclocarban, butylated hydroxytoluene (BHT), benzophenone, homosalate, benzyl salicylate, genistein and daidzein in the framework of Regulation (EC) 1223/2009.
The medical device nomenclature under the new Regulations on medical devices is now available.
The recently launched Medical Devices section on the European Commission's website was revamped to help smooth the transition to 2 new Regulations on medical devices and in vitro diagnostic medical devices. The portal presents the new regulatory requirements in various sections targeted at impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).
The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs is looking for observers to the subgroups of the Medical Device Coordination Group (MDCG)
This week's Business Planet travelled to Rome where an innovative young company Echolight has developed a new way to help Europe's ageing population with the help of EU funding.
A call for expression of interest for consultants with expertise in harmonised standards (HAS Consultants) is open. HAS Consultants will assess to what extent documents, or parts thereof, drafted by the European standardisation organisations comply with the European Commission's standardisation requests, and to what extent they deal with and support relevant essential or other requirements set out by the relevant EU harmonisation legislation.
The new lists of references of harmonised standards for medical devices have been published in the official journal of the European Union (OJ C 389 of 17 November 2017). They can be found below.
On 8 August 2017, the Commission adopted the decision on the qualification of the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon), is to prevent or treat cystitis.
