Issues on transposition of the IVD direcive

United Kingdom

Christopher Hodges

The Directive on IVDs was passed on 5 October 1998. Member States have until 7 December 1999 to implement it into their national legislation. Based on experience of the transposition of the AIMD and MDD, what lessons should be learned over transposition and on what points should industry monitor and lobby? The following aspects would be worth monitoring - no doubt there are others.

Incorrect transposition

A basic point is that a Member State may deliberately or accidentally create in its national implementing law differences from the Directive. Naturally, any draft and final law should be carefully monitored and errors raised so as to be corrected.

Consequences of incorrect transposition

Incorrect implementation of a Directive might expose a Member State itself to legal consequences. First, the Commission might refer the Member State to the European Court for a declaration that the offending part of the law is contrary to the Directive and invalid under Article 226 of the EC Treaty (as amended). Second, the courts might declare the same result in the process of other litigation, such as the Member State’s attempt to enforce the offending provision, perhaps through a prosecution in the criminal courts, or a citizen or company’s action in objecting to an executive decision, perhaps through seeking judicial review. An entity which suffers damage as a result of incorrect or late transposition of a Directive can, in some circumstances, obtain damages as compensation from the Member State under principles first established in the Francovich decision

Language of labelling

Article 4.4 of the MDD provides that a Member State may require the labelling of a medical device to be in its national language(s) when it is either placed initially on the market in its country or subsequently enters its national market. The cost of providing labelling in many languages can be considerable, without necessarily achieving a proportionate increase in safety. The use of national languages is, however, a political issue involving considerations of national sovereignty, identity, culture, consumerism and the Community principle of subsidiarity: it is an issue for all product sectors and is unlikely to be easily overcome.

EUCOMED lobbied national governments not to implement the MDD into their national legislation so as automatically to require national languages. This had limited but some success: use of English may be permitted or negotiated for some circumstances (usually for devices for professional use) in Finland (also for non-safety information), Netherlands, Norway and Sweden.

Greater progress was made on this issue when the IVDD was negotiated. Article 4.4 of the IVDD provides:

“4. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user.

Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official Community language(s).

In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:

(a) whether the information can be supplied by harmonised symbols or recognised codes or other measures;

(b) the type of user anticipated for the device.”

Further relevant provisions are included in Annex I(B) paragraph 8.1:

“Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer ...

Instructions for use must accompany or be included in the packaging of one or more devices.

In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them.

The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for device self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user.”

It will be important for the diagnostics industry to lobby national governments so as to achieve sensible transposition of Article 4.4 into national legislation. A number of questions arise over whether the decision on permitting foreign language labelling can be taken by the manufacturer or whether it must be subject to approval by the authorities. If the manufacturer can take the decision, he should obviously justify this in his technical documentation and be subject to challenge by the authorities. Would a mere challenge mechanism suffice or could he also be prosecuted if he gets it wrong? Would that be fair if the device had been imported into the country without the manufacturer’s knowledge? Surely that would be the importer’s responsibility? Alternatively, if each national authority’s approval prior to marketing is required, should this require formal approval by each authority (which might delay marketing) or a negative (or positive) exemption mechanism following notification to the authority? As with clinical investigations under Directive 93/42/EEC, should there be a time limit for the authority to consider the matter, after which device could be marketed in any event?

It does not take much thought to realise that national laws on this issue might vary enormously, destroying the principle of harmonisation. Should the governments be encouraged to adopt a unified approach?

It seems to me that the Directive requires the language decision to be taken on a product-by-product basis, although this could be developed into normally either mandating or exempting certain classes of product. The legal tests are:

1.Can the product be used safely and correctly if the labelling remains in the foreign language? This is an absolute precondition. However, it seems that the Member State still has a discretion even if this condition is fulfilled. It may be arguable that the State has no discretion, but the word used in Article 4.4 is “may” authorize, rather than “shall” authorize.

2.The Member State must take into account (and this wording supports the argument that it has a discretion) the principle of proportionality. This principle requires that the measure taken must not be disproportionate to the end to be achieved. Accordingly, it should be established that the translation of particular wording should not be disproportionate to the objective of achieving safe and accurate use of the device. This is probably a test of the relevant importance of particular wording - and not just the entirety of the product information - in terms of safety and accuracy. It would follow that information which is not important in relation to safety and accuracy does not need to be translated for regulatory purposes. Furthermore, the Directive specifically mentions that information could be supplied by harmonised symbols, recognised codes or other means, and this might make a requirement for translated words disproportionate. The Directive also mentions that the type of user might be relevant, and requires that labelling of devices for self-testing must be in the language(s) of the final user. Accordingly, it must be valid to conclude that the labelling and instructions for products for professional use may well not require translation - or, at least, complete translation. Indeed, there might be a presumption to this effect. There may, however, be some confusion over the definition of “professional”: should not nurses, midwives and technicians be included as clinical or technical professionals as well as medical professionals? Criteria may be useful.

The practical conclusion for companies might be that they should carefully divide the information which they provide with products into three categories:-

(a)Information which is required for regulatory compliance and which also relates to the safety and accuracy of the product. Subject to questions of proportionality, this information should be translated into national languages.

(b)Information required for regualtory compliance but which does not relate to safety or accuracy. This information should not be required to be translated. It will be sensible to make a clear delineation in the company’s documentation between the translatable and non-translatable information, and to justify the distinction.

(c)Any other information which the manufacturer might voluntarily wish to make available but which is not required for regulatory compliance. The manufacturer should document the fact that this information does not form part of the information required for regulatory compliance and is technically excluded from his technical information. There should, therefore, be no regulatory control on such information nor, accordingly, should it need to be translated.

Interestingly, the existence of a legal translation requirement could be relevant in the case of parallel imports. Whilst the general policy of the Community institutions is to facilitate parallel importation, the language barrier does act in effect as a barrier to trade. National legislation which requires translation into local language for a particular product would authorise the competent authority of that state to withdraw a parallel imported product from the market where its labelling has not been translated. This is a further reason why the implementing legislation should be monitored to ensure that no regulatory or criminal penalty is placed on the manufacturer for non-translation when this is not his fault, but any sanction should apply to the parallel importer. The translation requirements may, therefore, end up being used by manufacturers as a defensive hurdle against parallel importation. However, the above discussion shows that just because a parallel importer has not translated as much of the labelling information as the original manufacturer supplies with his official product in the relevant state, the parallel importer is necessarily breaking the national law, since the legal requirement should only be to translate information on safety and accuracy of use, taking account of the principle of proportionality.

Companies should, nevertheless, remember that while they may wish to cut costs by simplifying and not translating labelling wherever possible, issues of decreasing product liability risk must also be considered. Inconsistency of labelling between markets and incomprehensibility to users, can found product liability, despite strict regulatory compliance.

Enforcement issues

No regulatory Directive includes provisions for achieving enforcement. Issues such as regulator’s enforcement powers, powers to remove products from the market, criminal offences, sanctions and penalties are all matters which are within the competence of Member States. The obligation on Member States is to achieve the result intended by the Directive: how they achieve this is up to them.

Analysis of the Member States; laws on AIMDs, MDs, General Product Safety and other sectors shows that there can be considerable variation between countries in relation to enforcement powers and sanctions. It is often the case that industry gives very little attention to monitoring and commenting on these issues in draft legislation. This is a curious omission given the adverse impact which enforcement can have on a business and given the variations between States.

Authorised representatives and enforcement

The IVDD is more specific than the AIMD or MDD in relation to the requirement for and functions of authorised representatives. It is curious that these provisions have not been carried back into the earlier Directives by amendment - this seems to be an oversight rather than deliberate omission to make a distinction between the Directives. In essence, a manufacturer under the IVDD who is not established in the Community must appoint an authorised representative. The function of the authorised representative is to represent the manufacturer within the Community.

The specific legal obligations on an authorised representative have interesting consequences. First, he has “the obligation” to make regulatory documentation available on request to national authorities for inspection purposes for a period ending 5 years after the last product has been manufactured. He “may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under [the] Directive”.

The authorised representative should not take on his obligations lightly. He should ensure that he has a relationship of trust and close communication with his manufacturer. He should enter into a suitable contract with his manufacturer - a standard form is available from Cameron McKenna.

Whilst the functions of an authorised representative are generally clear, the Directive once again does not specify what enforcement consequences might occur if the authorised representative does not comply with his obligations. These matters are again left to national law and may differ. It is therefore likely that the powers and criminal sanctions which may apply to an authorised representative will differ from country to country. Accordingly, this may affect the choice of location of an authorised representative. Based on the general experience of the enforcement legislation under the MDD, one might predict that Germany would be a less attractive venue for an authorised representative and the UK and Ireland would be more attractive.

Technical documentation: don’t invent the wheel

The IVDD, like the AIMD and MDD, requires the manufacturer to keep technical documentation for regulatory purposes. This documentation can be complex and extensive. Considerable work has been done already in developing templates for the format of various essential documents (such as control of compliance with essential requirements and risk assessments) which are available on disk. Adoption of standardised documentation has the advantages of saving cost and developing common industry practice. These precedents should be seized on by the IVD industry.

Own-brand labelling: who is the manufacturer?

It is important to remember that when the IVDD uses the word “manufacturer” it is using this in a precise, defined legal meaning which may be different from common speech. A regulatory “manufacturer” is not necessarily the person who makes the product.

The definition of “manufacturer” is Article 1.2(f) of the Directive is:

“The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under this own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.”

Thus, a “manufacturer” for the purposes of the MDD is the person who has regulatory responsibility for a product by having responsibility for the four functions named and places the device on the market under his own name. Only one legal entity may be a “manufacturer” of a medical device. It is clear that the “manufacturer” need not physically undertake any or all of the functions of design, manufacture, packaging or labelling: these may be carried out by sub-contractors on his behalf. Thus, a person who is a legal “manufacturer” may be an own-brander (applying his name to a product made by someone else), but he must place the device on the market under his own name.

The label and instructions for use must bear the name or tradename and address of the manufacturer. For devices imported into the Community with a view to their distribution in the Community, a label, the outer packaging, or the instructions for use shall contain in addition the name and address of the authorised representative of the manufacturer.

Where a device is made by one company (the maker) and placed on the market bearing the name of another company (the brander), the brander will be the legal “manufacturer”. The brander must therefore keep the declaration of conformity. There should be a contract between the two companies setting out their obligations in relation to maintenance and access to technical documentation (design and production), adverse event reporting and so on. Standard form contracts are available from Cameron McKenna covering this situation.