The Material Passport Scheme -
where we are!
By Jonathan Bill, Vice-Chairman, DLA
Changes to the European Directive MDD 93/42 EEC
On the 28th June 2007 DLA representatives Richard Daniels (CEO), Graham Findlay, David Smith and myself met with the MHRA in their London Offices.
The purpose of the meeting was to discuss the changes to the European Directive MDD 93/42 EEC. We have more commonly called this the Material Passport Scheme. This change was originally proposed and put forward after discussions between the Dental Laboratory Industry and the Commission to include: ‘that the declaration of conformity be passed onto the patient and to include information about any sub-contractors’. The time scale as is available now, is that the UK has 15 months to transcribe the changes into UK law and then another 15 months for UK manufacturers to comply with the changes.
However, the proposal was amended by the EU Parliament and the Council of Europe to ‘Shall be made available’ and the requirement to include sub-contractor information only needs to be kept in the records. This change, at the time was a major disappointment to us all when we first heard the news in Cologne, but have since been encouraged in the fact that there is a possibility the UK could adopt it. It was recommended that our next port of call was the MHRA as they could help the process to go through. This proved a little more difficult than anticipated as the MHRA insisted that they were not responsible for the decision to not fully implement the changes proposed by the Commission. Though they did say that they would like to work together on some guidance, which may help with the interpretation of these amendments, but would not support changes if they were included when subscribed into UK law.
This I might add was not a surprise as I was warned the MHRA would probably be the most awkward body to get on board. However, on a more positive note, they did ask us for our help to draw up a procedure with them on how their inspections could be more transparent and consistent. The reason being that the MHRA inspections are now being audited by an outside body and they are concerned that potentially their inspections in the past would not meet the auditor’s requirements. They did stress that they took seriously any complaints about materials or businesses not complying with the directive and if the DLA had evidence of illegal practice they would investigate any such occurrence. The matter of making the list of manufacturers public would take some time as they clean up their lists in readiness for the information to be published.
The final part of the meeting proved interesting, as in previous parts of our discussions we were told by the MRHA that they were not bothered where dental appliances are manufactured, i.e. this country or abroad, as long as they met their requirements. Therefore, patient safety would not be compromised.
Our argument centered on the fact some countries were not using CE marked materials and the material passport scheme we were proposing to adopt would allow the patient and practitioners to see what materials were actually going into their mouth. We also argued that even some materials with CE markings were not desirable for the mouth. This is when we introduced the subject of NPG, by giving them two identical looking crowns. One made from 60% gold and the other made from NPG. We asked them to tell us which was which and although they gave a confident answer they picked the NPG crown as the high gold content crown. We then informed them of the constituents of the NPG, which include 80.7% copper, 7.8% Aluminum plus a few other metals we would not like in our mouths.
At this point I feel that they got an understanding of where we had been coming from, especially after we explained that large quantities of this alloy was being sold in the UK. We also informed them that a surgeon could fit a crown made from this alloy, privately, but was banned from doing so under the Health Service. They are to look into the matter.
We felt the meeting went as predicted, but a few positives came to light, which we hope to build on over the coming
months.
Next stop will be the Department of Health.
