Last Friday, May 5th, 2017, the European Parliament and the Council of the European Union published the new regulations (EU) 2017|745 on medical devices and 2017|746 on in vitro diagnostics medical devices. Next to major changes on regulation regarding the classification of products and on the performance evaluations studies for IVD and regarding the new requirements on clinical evidence and clinical investigation studies for MD, also the regulation regarding IFU’s has changed.
In Annex I, Chapter III, Point 20.1 of the regulation for IVD’s or Annex I, Chapter III, Point 23.1 of the regulation for MD’s is written:” Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website...”
Because of this new regulation, you must set up a system to make the IFU’s available on your website. Why not turn this obligation into an opportunity and leave out the paper IFU’s at the same time, saving on paper and logistics cost and making use of all the advantages a flexible digital carrier is offering? At Qarad we are convinced it would be the right time and for sure worthwhile to combine both.
Qarad’s e-Labeling Services is a single supplier solution for your e-IFU’s developed by an experienced team of regulatory and quality experts. It is fully compliant with EU and FDA regulations and the concept is familiar to and thoroughly reviewed by the major EU Notified Bodies. More than 50 companies, including industry leaders, store their IFU’s on a customized website on our standard platform or on a tailor-made website supporting all their requirements and are using these services for several years to their full satisfaction. As an experienced specialist in e-IFU’s, offering already a fully compliant solution, we are ready to help you to save time and cost, time that you will need for the other aspects of the new regulation. Click here for more information on e-Labeling or contact us for a free remote live demo.
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As established by the Lisbon Treaty signed on December 2009 the European Commission can use these type of 2 acts in order to ensure the implementation of EU laws. Essentially these acts correspond to the creation of detailed rules to add substance to higher-level legislation such European Regulations or Directives. The EU Commission may use the assistance of informal committees made up of experts from Member States in a process known as “comitology”. Delegated and Implementing Acts are defined in articles 290 and 291 of the Lisbon treaty; the official definition of a Delegated Act is: “a non-legislative act of general application to supplement or amend certain non-essential elements of a legislative act”. Implementing Acts are to be used where uniform conditions for implementing legally binding Union acts are required. Delegated Acts are closer to law-making and focus on the “what” while Implementing act is more focused on the “how”, on the practical implementation of rules that already exist in the original legislation. Delegated Acts (DA) Because issuing a DA is considered a “quasi-law-making” action the EU Parliament & Council are primarily involved in their review and have the power to scrutinize and control the DA-issuing process. They can raise an objection to any DA (within 2 months) and have the power to prevent it from coming into force. Parliament1 and Council2 even have the power to revoke the Commission capability to issue DAs for specific legislations. In this case Commission can’t issue anymore DAs but all previously published DAs stay valid. 1 majority required 2 qualified majority required Implementing & Delegated Acts for the IVD-Regulation Nobody knows yet exactly which IAs or DAs will have to be prepared by the Commission in order to provide a practical implementation context to the future EU IVD-Regulation. For the moment the Commission has just stated that they foresee the need to issue approx. 15 DAs and 24 IAs for the IVD-R (similar numbers for the MD-R). This may amount to thousands of regulatory pages which potentially may need to be written. The Commission also stated that they will work according to these priorities:
The Commission already stated that the MDCG is the main body which will support the commission in implementing the future IVD/MD Regulations. It will be formed by experts nominated by the various Member States and will be chaired by the Commission. Qarad believes that the MDCG won’t be nominated till some months after the publication of the final texts of the IVD-Regulation and then it will take still several months for the Commission to publish the most urgent DAs and IAs. We also have to keep in mind that it will take equally long, if not more, for Notified Bodies to apply for nomination to the IVD Reg. (1st), to be assessed for adequacy (2nd) and then to be officially nominated (3rd). This may mean that for the first 12 or even 18 months of the transition period it will be simply impossible for any IVD manufacturer to CE-mark its products as per the IVD-R. The required and much needed DAs and IAs won’t be there yet and, on top of it, there won’t be any NB yet to issue the CE certificates. Only Class A IVDs, the only ones which will still be “self-certifiable”, could be placed on the market under the IVD-R regime. Anyway, the very few which will still be some left in this class… Qarad keeps following very closely the proceedings of the EU IVD-R and will keep you posted with future newsletters.
New European Data Protection legislations. What are the implications for industry? At the end of April this year Europe has published two key documents:
While the Directive is essentially aimed at Member States in order to clarify their obligations in tis field, the Regulation is aimed to industry and all those entities which find themselves included in the definitions of Data Controllers and Data Processors.
Please read on to learn more by clicking here.
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