Publication of the IVD-R and MD-R

Qarad is glad to inform you that the new European Regulations for Medical Devices and IVDs have been published in the European Official Journal on May 5, 2017.

This publication represents the conclusion of a five-year legislative process but, at the same time, it’s the beginning of a new European regulatory regime which will have to be dealt with by manufacturers world-wide for the next 20/25 years as predicted by the European Commission.

The new EU regulatory framework will be much more demanding than the current directive-driven ones.
The most challenging areas will be in the field of Clinical Evidence, the Risk/Benefit ratio, the introduction of UDI and, for IVDs, a classification revolution which will bring almost all IVDs under the direct control of Notified Bodies.

Manufacturers of those (rather few products) falling into the MD-R Class 1 (non sterile, non measuring) and the IVD-R Class A will be able – if ready – to start CE marking their products under the Regulations regime starting from May 26th because the Regulations officially enter into force (= beginning of the transition period) 20 days after the publication.

However all manufacturers of products above the self-certification classes will have to wait from 6 to 12 months before they will be able to CE mark their products under the Regulations for the very simple reason that this is how long it will take for the Notified Bodies to file their applications and to have them reviewed and accepted by their respective Competent Authorities and other experts as per the joint assessment procedure requirements.

This is just the beginning of a long and complex path that all MD manufacturers will have to walk at a certain point in the next 3 years while IVD ones will have 5 years (duration of the transition period).

Qarad will be issuing regular newsletters focusing on specific issues or items of the regulations.
As always Qarad will be there at your side in order to help you in the process and ensure a successful transition from the current Directive to the future Regulation framework.

Click here to read the entire IVD-R and MD-R

Impact of the new IVD-R and MD-R on eIFUs

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.

Meet Qarad worldwide!

Qarad attends events, conferences and exhibitions around the world!

We look forward meeting you at one of the following events:

  • May 15 - May 16: RAMD: World Congress on Regulatory Affairs for Medical Device, Amsterdam, the Netherlands (*)
    Qarad is pleased to tell you that our own expert, Dr. Maurizio Suppo, is speaking at this event.
  • May 18: Knowledge for Growth, Ghent, Belgium
  • June 14 - June 15: SMi IVD Conference, London, UK (*)
    Qarad is pleased to tell you that our own expert, Dr. Maurizio Suppo, is speaking at this event.
  • June 21 - June 23: Informa MedTech Summit, Amsterdam, the Netherlands (*)
  • July 30 - August 3: AACC 2017, San Diego, USA
  • November 13 - November 16: Medica, Düsseldorf, Germany

(*) Qarad is an official sponsor of these events!

Please feel free to contact us if you want to meet us at one of the events!

What are “Delegated and Implementing Acts”?

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:

  • Notified Bodies
  • Common Specification on Annex XV devices (without a medical purpose)
  • Reprocessing of single-use devices
  • Governance: Setting up the MDCG and Expert Panels

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

New European Data Protection legislations. What are the implications for industry?
At the end of April this year Europe has published two key documents:

  • The new European Regulation 2016/679 on General Data Protection Regulation (GDPR)
  • The new European Directive 2016/680 on General Data Protection Directive (GDPD)

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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