In the mean time: a Staff Working Document

European CommissionIt’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going on in the medical devices regulatory developments field.

Yes, market parties have been working on their input for the consultation about the Green Paper on mHealth with its many questions and the Greek Presidency was working on trying to get the Member States to align to some kind of result on the Medical Devices Regulation project (nobody is talking about the IVD regulation – quite unjustly so I think) but nothing unexpected so far in that field.

And of course this blog won a nice award, which was great recognition:


When the Commission finally issued its Staff Working Document (SWD) on the Joint Immediate Action Plan progress so far last Friday, however, things got very interesting again. Why? Because it gives some interesting insights in market surveillance and accreditation of notified bodies for the future, and allows us to connect dots that may not always have been very obvious (not to me at least).

Industry was happy with the SWD and what it implies for future medical devices market access and surveillance in the EU. Not surprising that they are happy with it, because it wants the Commission and the Member States on its side in the negotiations to come about the revision of the EU medical devices and IVD directives, which still seem to be slated for somewhere first half of 2015, against the Parliament’s proposals for change in these dossiers.

Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices legislation

The SWD spends considerable space reiterating its background: breast implants, metal-on-metal hip replacements and vaginal meshes. Main actions set out in the plan:

Notified bodies : Member States were asked to revisit their designated notified bodies and to provide the Commission with an updated list of the notified bodies designated for class III medical devices, to make their notified bodies do unannounced audits and to require notified bodies to receive vigilance reports from their manufactures.

Market surveillance : Member States were asked to inform the Commission how they are fulfilling their market surveillance obligations under regulation 765/2008.

Coordination : Member States were asked to coordinate surveillance activities, which they have traditionally been notoriously bad at. The Joint Plan however called for increased coordination, in particular in the field of audits and market surveillance, to be established in the framework of the confidentiality arrangements signed with international partners.

Communication and transparency : another area that Member States were never very good at. The Plan foresees UDI guidance (as many member states are not waiting for the Eudamed cathedral to come online and are implanting their own systems which may not work with Eudamed or other Member States’ systems) and setting up of registries. Not that surprising, since national governments are under pressure locally to do something UDI-ish to organise the medical devices market into a safer place.

So what was achieved?

Actually, surprisingly much. Chapter 2 of the SWD mentions:

Notified bodies : a lot has happened in the field of notified bodies accreditation and oversight (and rightly so). Every manufacturer that has devices certified by a notified body and especially those that are in the process of having them certified has noticed that notified bodies have started to behave quite differently and are moving the goalposts on clinical evidence during the conformity assessment procedure. Why? Because Member States have gotten a lot tougher on notified bodies regarding their designation, monitoring and functioning as a consequence of the Commission Implementing Regulation on the designation and the supervision of notified bodies. Also, further to the Commission Recommendation on the audits and assessments performed by notified bodies in the field of in the medical devices sector notified bodies have been required to start conducting unannounced audits on their manufacturers and their supply chain.

From the SWD it is clear that the intensified (joint) supervision of notified bodies has had a significant impact on the market with corrective measures, limitations of designations and withdrawn designations. Member States have started joint assessment audits, resulting in several notified bodies stopping activities, some caused by a joint assessment. The problems identified in the assessments are worrying as “the most common problems identified with regard to notified bodies relate to the:

– evidence of staff qualifications;

– thoroughness of the review of manufacturers clinical evaluations and

– sampling of technical files for class IIa and IIb devices.”

The picture is that many notified bodies are not organized in a way that they can fulfill their tasks effectively (like most of the authorities by the way – the SWD paints a picture of understaffed and under-resourced competent authorities), which is evidence of a broader policy problem: apparently medical devices oversight is still a bit of an orphan area of Member State supervision policy.

Market surveillance : this was one of the areas where the least development was seen. The Commission merely concludes that “Many of the Member States recognised that because of a shortage of resources, market surveillance is only reactive and that no proactive surveillance is carried out.”

Coordination : a lot was achieved in this area, see § 2.3 of the SWD for details. Some of the highlights:

(1) streamlining and monthly discussion of NCARs (National Competent Authority Reports, the instrument for dissemination of vigilance information) and specifically set up of “a monitoring system on the follow-up and a dedicated web space for storing background documents have been put in place” as well as launch of a pilot project on analysis of medical devices incident reporting by the Joint Research Centre (JRC) of the European Commission in the summer of 2013. This will be developed further in the IMDRF efforts under the “National Competent Authority Report (NCAR) Exchange Program”, with concrete steps envisaged in autumn 2014 at the IMDRF meeting. Since confidentiality remains a problem in exchange of information, says the SWD, bi- or multilateral agreements may be necessary to implement this satisfactorily.

(2) a pilot on joint market surveillance under the Compliance and Enforcement Working Group (COEN) to launch joint market surveillance projects between Competent authorities (limited success with only ten Member States responding to the call and six of these finally being able to provide full reports on the outcome of the project on national level, so cooperation is still not really in Member States’ genes and (I think) budgets.

Communication and transparency : We had the UDI recommendation, Member States are trying to engage doctors and patients to warm to registries, and measure to improve incident reporting involving medical devices by patients and doctors (“On the basis of these replies, the Commission has suggested a number of actions which could be taken by the Member States under the present legislative framework to facilitate reporting by healthcare professionals and patients, such as further measures on national level to encourage reporting and the development of standard web-based structured forms.”). Incident reporting by patients and doctors remains (as I have argued) one of the flaws in the new regulations because they merely gently prod Member States to “encourage” this rather than make it mandatory, probably because the Commission is not sure whether it can impose this by regulation.

Brace for Joint Plan v 2.0

As I have predicted, a Joint Action Plan 2.0 now seems definitely to be in the works. In the words of the SWD:

“Many Member States and stakeholders have underlined the importance to continue and intensify the work on certain aspects of the Joint Plan. The focus should be on problematic issues identified during the implementation of this plan that are not yet resolved”

Some of these issues are

  • coordinating Member States market surveillance actions with respect to specific products, including exchange of data and approaches;
  • implementing the new notified bodies acquis and holding notified bodies to the standards set out in their Code;
  • pursue making best use of registers for providing data and identifying problems with devices that has been launched under the Joint Plan under the current PARENT Joint Action and in follow up actions envisaged;
  • share more knowledge and good practices.

But that is not all, says the SWD, because this is what’s possible under the current legal framework:

“For other important aspects, it is not possible under the current legal provisions to reach the desired objectives.

Therefore the proposed new Regulations contain provisions which aim to solve in particular the problems relating to:

• the scope of the legislation,

• the governance of the system and its transparency,

• certain obligations of notified bodies, in particular in relation to mandatory unannounced audits,

• clinical evaluation,

• the risk classification of devices and the safety and performance requirements,

• obligations of economic operators,

• reporting of incidents by users and patients to the Competent Authorities,

• certain aspects relating to vigilance system and market surveillance,

• the role and the functioning of the database Eudamed and the access of notified bodies to Eudamed, and

• the traceability of devices.”

But in the mean time – where is the revision now?

Work also continues on the revision with the Greek Presidency running to an end and the Italian one ready to start. Where we are with that I will tell you in a next blog, in which I will also report on the ESPCO Council meeting of last Friday, which summarized the results of the Greek Presidency in the MDR and IVDR dossiers. But I can already say it’s not developing that fast that it can’t wait until the next blog.

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