The European art of compromise – new draft devices and IVD regulations published

In a fleet footed bit of political compromise, the Latvian presidency publishes compromise texts for discussion at the EPSCO (health ministers) council on June 19. There’s plenty of give and take more than a few surprises.  There’s still much unknown as this compromise text does not include the Annexes or the preamble.

Here’s a few highlights, in no particular order, from a first review of the texts.

Clinical Trials

As expected there’s lots of detail in Article 51 on clinical trials and stronger regulations including quite specific requirements for member state authorisation, separate ethics committee review and requirements for safety precautions including preclinical and technical testing of investigational devices.

Authorised representatives must step up

The new text places far more responsibility on EC representatives.  The EC representative will be required to satisfy themselves that the manufacturer holds the necessary Technical File evidence of compliance and  that appropriate conformity assessment has been applied.

EC reps will no longer be required to employ directly qualified safety officers, but are allowed the flexibility to demonstrate direct and continuous availability of such persons (e.g. through sub contract)

The really big change is that in the ase where the manufacturer has no legal presence within the European Union, the EC rep is required to take direct product liability for the device or IVD.

Given these changes the right choice of EC rep will matter more than ever.  Simply citing the address of a sales office or distributor won’t cut the mustard.  The EC rep needs to be competent, do their due diligence and hold insurance.  There’s been much talk of a shake out in Notified Bodies – expect to see the same in EC reps – with those remaining having better processes and offering more added value.  But this will come at a cost – expect EC reps to charge higher fees and be much more risk averse (nobody likes to be sued for someone else’s mess).

Reprocessing – some wiggle room

The proposal allows for reprocessing – subject to conditions…  expect Europe wide minimum technical conditions, exemptions for in-hospital reprocessing and a list of prohibited devices which may not be reprocessed.  The text also provides for additional limits or prohibitions under national laws

Free nomenclature codes at last?

One interesting change is the requirement that the commission make available free of charge a nomenclature code for use in the pan-European Eudamed database.  This may see an end to charging for access to GMDNS or its (UDI) replacement.  Meanwhile, while the implementation of nomenclature plays out, GS1 AISBL, HIBCC and ICCBBA are all designated as UDI assignors.

Stand alone software no longer “active”

The old text stating “Standalone Software shall be considered an Active Device ” is deleted.  Should make for some interesting changes in classification of software.  Much will depend on the final text of the classification Annex which is missing (see below)..

Clearer definition of  accessories

There’s a new, longer and more prescriptive definition of accessory devices.  Article 2(2) states accessories  are things intended to specifically and directly assist the medical functionality of the medical device(s) in view of its/their intended purpose(s);”  

Clarity for tissue engineers?

There’s a proposed new Annex on Non medical Devices and a new clause on borderline considerations for devices which may fall into the Tissues and Cells Directive.  The text is yet to be drafted but there’s at least consideration of new technologies.

Acceptable Risks and Safety

There are clear definitions of safety in both documents which state that

safety is the absence of unacceptable risks, when using the device according to the manufacturer’s instructions for use

That should introduce a welcome dose of practicality into the application of ISO 14971.  There was much consternation when the 2012 EN version appeared with a new Annex Z which dispensed with the concept of acceptable or unacceptable risk and required manufacturers mitigate all risks to the maximum practical extent regardless of cost.

Adverse Events and IVDs

The definition of adverse event is tweaked in the IVD regulation draft to incude “inappropriate patient management decision.  It’s now abundantly clear that an injury resulting from a misdiagnosis is an adverse event.

Lab Developed Tests

There’s setting out expectations for laboratories developing LDTs to be QA certified to ISO 15189 AND national accreditation schemes. Labs making Class higher risk class C and D tests must also prepare and hold technical file evidence sufficient to enable a competent authority to establish the compliance with Essential Requirements.

Internet Sales of Diagnostics – Take it down!

Article 5 includes provisions requiring compliance with the regulation of devices supplied via Internet commerce or used to provide diagnostic services offered via Internet commerce.  The Regulation also provides that:

A Member State may on grounds of protection of public health, require a provider of
information society services as defined in Article 1(2) of Directive 98/34/EC to cease its

In other words – a member state may on public health grounds to instruct an ISP to take down a website offering diagnostic testing.

These are broad reaching provisions and it remains to be seen how enforceable they may be.

What’s missing?

Well quite a lot actually.  these texts are without the vital Annexes – which contain all the technical detail of things like assessment processes, classifications and Essential Requirements.    There’s also no recitals – which are so important in judging intent when it comes to disputes over interpretation.  So there’s still a long way to go on the essential detail.  Nonetheless – these texts have gone a long way towards finding a compromise solution.  It will be fascinating how this plays out from here.

A complete package?

The Note from the presidency to the Council makes it clear that they belive this to be a balanced package, and exhorts the Council to resist tinkering with the proposed text:

The Presidency is of the opinion that the two texts it prepared are balanced compromises that while being internally consistent seek to respond to the plenitude of amendments suggested by delegations and the concerns raised by them. The Presidency underlines that those texts should be seen as a package and recommends to the Council to reach Partial General Approaches on both proposals without making any changes to the texts.

In short – stop picking on the detail and stand back and see the big picture here.

To download the texts click the links below:

Need help in navigating CE mark?  Contact us – for details on how we can assist you in understanding European Conformity Assessment, developing a European market entry strategy and all the steps to CE mark including , compiling the technical file, selecting a Notified Body and preparing for audit.  Our trusted partner MT-Promedt offers a complete EC representative service.

Help button-Quick Call-Brandwood BiomedicalNeed help in navigating CE mark? We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.

Contact us – for details on how we can assist you in understanding European Conformity Assessment, developing a European market entry strategy and all the steps to CE mark including , compiling the technical file, selecting a Notified Body and preparing for audit.  Our trusted partner MT-Promedt offers a complete EC representative service.

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