Schermafbeelding 2014-04-04 om 22.38.34

After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first.

Some history

But first, for those who are not familiar with the Blue Guide, a little bit of history:

“The Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework (NLF) for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty (in force since 1st December 2009) with regard to the legal references and terminology applicable to EU-related documents, procedures, etc.”

To me the Blue Guide from 2000 has been immensely helpful for interpretation of crucial concepts in medical devices legislation, like ‘manufacturer’, ‘authorized representative’ and ‘placing on the market’, just to name some. And its fabulous flow charts outlining conformity assessment procedures made things a lot more transparent.

What is new?

The Blue Guide itself says:

“This new version of the Guide will therefore build on the past edition, but include new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardisation or market surveillance. The Guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of Union harmonisation legislation and not only by the so-called “New Approach” directives.”

But there is more. I was very happy to find a relatively comprehensive guidance on international aspects in the form of pretty detailed discussions of international (with that I mean: outside of the EU) aspects of CE marking, including mutual recognition and geographic scope in chapters 2.8 and 9. This was already addressed in the old Blue Guide, but this update is current now and more detailed.

The chapter 7 on market surveillance contains a discussion of the new (not so new anymore) provisions on customs competences with regard to CE marked goods. Always convenient to know if you consider enlisting customs to help achieve your purposes which we love to do as litigious people that lawyers are.

There is a new 1 page chapter (chapter 8) on Free Movement of Products Within the EU, which discusses the free movement clause and restrictions / limits that the member states still impose. It is unfortunate (to say the very very least) that the Commission has not been able to include a discussion on the consequences of the Lycocentre-case. This EU court  judgment, as I have blogged, puts a major stick in the wheel of free movement of medical devices in the EU internal market. A discussion of its consequences for free movement would have been more than welcome in this chapter. Also, this big flaw in the internal market for medical devices something that could still be fixed in the proposals for the IVD and medical device regulation, which include limited powers for the Commission to make central qualification decisions. However, this limited step forward will not protect companies against the often very poorly supported reasoning that member states use to qualify products differently. The scientific quality of qualification decisions by member states can be disappointingly low and sometimes is just downright and objectively wrong. The Lycocentre case makes it much easier for member states to get away with their version of science. Going to court over what the correct scientific conclusion must be is, as you can imagine, not a nice prospect because judges are not scientists either and are inclined to give authorities the benefit of the doubt if their are not manifestly besides the point.

What is interesting –  authorised reps

As I have blogged before, the legal status of authorised representatives under the medical devices regime has my special attention at the moment. Consequently, I was puzzled to see the following statement casually scuffled away in footnote 57 on page 19:

“Please note that in the area of medical devices, the role of the authorised representative is reinforced and he is the primary interlocutor of market surveillance authorities for products for third countries.”

What is meant by “reinforced” here? I am pretty sure I have not missed an amendment of the medical devices directive and subsequent amendment of national law since the last amendment in 2007 in directive 2007/47. I am also pretty sure this is not a reference to the definition of the concept in Regulation 765/2008, which, admittedly, does define the concept differently but does so in a general way, and not specifically for medical devices. Also, regulation 765/2008 actually seems to do the reverse of reinforcing by using the words “act on his behalf in relation to specified tasks” rather than the wording of  “acts and may be addressed [...] instead of the manufacturer” used in directive 93/42 (which the Dutch authorities have taken to mean now that you can enforce against and fine the authorized representative for whatever regulatory mistake the manufacturer makes).

765/2008 Directive 93/42
‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter’s obligations under the relevant Community legislation; ‘authorised representative’ means any natural or legal person  established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;

 

Perhaps the reference is to the MEDDEV on authorised representative? But that MEDDEV starts with a disclaimer that it is not legally binding and that it reflects “positions taken by representatives of interested parties in the MEDICAL DEVICEs sector”. It does provide for some additional guidance in the section B. Member States’ Expectations in which member states’ expectations in some scenarios of noncompliance by the manufacturer are discussed:

“- In the event of a disagreement, where the authorised representative considers that the manufacturer is not complying with the requirements of the Directives, it has a duty to communicate this to the manufacturer. If the disagreement continues, the matter should be submitted to the authorised representative’s Competent Authority for decision. The authorised representative may opt to rescind the contract.

- In the event of a clear non-compliance by the manufacturer that could engage the responsibility of the authorised representative and which the manufacturer refuses to correct, the authorised representative has the right to rescind his contract with the manufacturer. The authorised representative has even the obligation to rescind the contract if the non-fulfilment of the manufacturer’s obligations causes him to infringe national law. It should then notify his Competent Authority and the manufacturer’s Notified Body of this.”

It is unclear to me however how this ‘reinforces’  the authorised representative role, because it just says that member states expect authorised representatives to structure their contracts to include specific agreements. It also suggests that authorised representatives have certain rights to terminate their contract, which, as I have blogged, utterly lacks legal basis because a MEDDEV cannot intervene in national contract law and therefore cannot ‘reinforce’ their rights.

To conclude, I am very interested to understand what the Commission means with what looks to me like a slip of the keyboard. Anyone of you readers that can help me understand this?

More to come

This was the first of my series of blogs on the new Blue Guide. Watch this space for more.