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Intended Use VS Indications For Use

Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! So why does it matter?

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do. This is precisely why the classification will be based on the intended use, that is, on the manufacturer’s claims. It is good practice to keep the intended use statement concise, as long as it details all the fundamental claims appropriately.

On the other hand, the “indications for use” will lay out the conditions in which the user would use the device, that is, the reason or situation for use.

If you have any further questions, please let us know!

Gap Analysis to the new Medical Device Regulation EU 2017/745 (MDR)

This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now!

Manufacturers across the world are not only planning to transition to the MDR they are also transitioning to the new QMS standard ISO13485:2016, which must be completed in 2019. Notified Bodies are already quoting extended lead times due to shortages of staff and other operational issues, it makes sense therefore to commence your planning process, don’t get caught out!

With our team of experts Advena can help and guide you through the transition process from MDD to MDR.

Our comprehensive MDR gap analysis, reviewing your current technical file, will highlight gaps, deficiencies or non-compliances in your documentation and processes, this will be presented via our in-depth gap analysis report, with suggestions and recommendations on how to fix these in readiness for your first MDR audit.

For more details please contact our team: info@advenamedical.com

Breaking News – The New Regulation on Medical Devices (MDR) and Regulation on In-Vitro Diagnostic Medical Devices (IVDR) are now Published

On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives.

These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after entry into force for the Regulation on in-vitro diagnostic medical devices.

With these new Regulations the burden of responsibility increases on all commercial entities, especially EU Authorised Representatives such as Advena, therefore the times ahead are expected to be challenging for all concerned.

Advena with our team of experts and range of services are well placed to help and advise clients through the applicable transitional period.

In-Vitro Diagnostic Medical Device Regulation

It would seem like the new IVD Regulation (IVDR) has been behind the scenes, overshadowed by the Medical Device Regulation (MDR). The IVDR brings with it a totally new classification system, which resembles that of medical devices. Previously, IVDs were classified as either general, self-testing, list A or list B devices. In contrast, with this old system, IVDs will now be classified as D, C, B, A, or other, in descending order with respect to the risk posed by the device.

As a snippet of the changes being made in this Regulation, all self-testing IVDs will fall under class C, except for those devices used to detect pregnancy, test for fertility, determine cholesterol levels, and devices which are used for the detection of glucose, erythrocytes, leucocytes, and bacteria in urine, which are classified as class B.

To determine the classification of a device, one must first consult the classification rules (of which there are seven) highlighted in Annex VIII of the new Regulation. Every manufacturer currently following the IVDD should definitely have a look at these new rules, as we are aware that many devices will need to be “up-classed”, and therefore may require Notified Body involvement. If you are an IVD manufacturer and are concerned about what changes the new Regulation may mean to you, please do not hesitate to get in contact with us. We would be able to propose a classification with respect to the IVDR, and also establish which conformity route should be taken.

The commission is currently focussing on establishing both the Medical Device Coordination Group (MDCG) and the EU Reference Laboratories (EURL). The latter are to be established 18 months before the Date of Application (not 6 months as previously thought). Class D devices will be subject to a control by EURLs and may also be subject to a scrutiny mechanism by an expert group.

The MDCG is a proposed group that will investigate assessments of high-risk devices made by Notified Bodies. The group shall be formed of national representatives, and will carry out their investigations prior to the product being placed on the market.

There is also considerable work being done with respect to companion diagnostics. Currently, there’s a lot of focus on molecular profiling, however it is thought that other technologies may also play a vital role: Immunohistochemistry, traditional immunoassays, protein profiling using microarrays, and mass spectrometry. Furthermore, there is a need to review certain elements of companion diagnostic devices, in particular specification.

With Task Groups still looking into vigilance, establishing expert panels and laboratories, it seems like the Regulation is going to be based on rocky foundations as the details of these are still to be determined. It may be that a classification guidance of some sort will be required, since no doubt the new classification system will bring out some borderline devices which are hard to place in one class. We now all await the end of May for the official publication in the EU Official Journal, and watch how all this unfolds.

Medical Device Regulation: Technical File Requirements

There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to support their marketing activities in the EU.

In addition, as from mid-year (probably May / June), anyone who exports medical devices into the EU may have to assure that their importer, and authorised representative (such as ourselves), has suitable access to the company technical documentation to demonstrate conformity to the regulations. So, in that respect, importers and authorised representatives could be asked to show how they can gain access to device technical files in a timely manner. To not be able to do this could mean exposure to legal issues and, in particular product liability claims, as all economic operators could be held liable to assure device conformity.

We strongly urge these processes to be considered as soon as possible before the new EU regulations are upon you;

  1. Assure you have up-to-date, signed and approved regulatory files that are reviewed for completeness. Such files should concentrate on safety (by risk management) and a demonstration of conformity to the EU “Essential Requirements” (Now called “General Safety and Performance Requirements” in the Regulations) by using a check list. All manufacturers selling in the EU must have a suitable “Declaration of Conformity”. If you are an Advena Ltd. Authorised Representative client you will know we insist on the latter before we will contract with you.
  2. Assure that your importers (that is the businesses who first bring your devices into the EU – you may have several) understand their responsibilities for being able to access your technical data.

NOTE:    Having access to technical files does not mean the economic operator having the information physically on file in their premises, although this may be the way you want to work.  As most technical file documents are live, and subject to continual improvement and update, this information could be on a cloud server with permission to be being given in the event of a regulatory enquiry. However, Authorised Representatives must be able to show they have verified that the text is available and complete.

Any Non-EU medical devices manufacturers seeking an EU Authorised Representative (EC REP) should contact Advena Limited by email: info@advenmedical.com to request detailed information about our services and a quotation.

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