The EU in Brussels has been discussing the draft of a new Medical Device Regulation (MDR) since 2012. In September 2013, the EU Commission anticipated some of the new provisions and introduced clear requirements for unannounced audits at the manufacturers of Medical Devices. We talked with Hans-Heiner Junker, TÜV SÜD Product Service, about the forthcoming changes in the approval and postmarket surveillance of Medical Devices.
The EU already has a common Medical Device Directive (MDD). Why is it now planning to introduce a new regulation?
By establishing a common regulatory framework, the EU intends to exclude differences in the quality of the approval processes in the individual member states. In addition, the EU wants to install a better system for postmarket surveillance to ensure more vigilant monitoring, particularly of high-risk products. And aligning the European legislation to the state of the art is definitely necessary.
Which areas have been affected by divergences between European approval procedures in the past?
Discussions have focused on the qualification of the responsible parties and standardised testing methods of the EU Notified Bodies. So far, the EU has not established uniform criteria concerning the qualification of the individuals responsible for conformity assessment or the designation and surveillance of Notified Bodies.
What are the top three new requirements that manufacturers will have to fulfill in the future?
So far, there have been two separate European Directives for Medical Devices and active implantable Medical Devices. The EU will now summarise these two separate directives in one EU Regulation. In detail, the new Regulation will introduce improvements regarding the conformity assessment procedure, the requirements for assessment of the clinical investigation of new products, and the criteria for technical documentation.
When will the new MDR come into effect?
No further consultations on the MDR have been scheduled before the European elections in May. Given this, everything will depend on how quickly the new parliament and the new EU Commission can familiarize themselves with the issues after the election, and what priority they place on advancing the MDR. Following publication, the EU Regulation will probably come into effect within three years.
After the PIP scandal, the member states are under pressure to improve patient safety. Can we actually afford to wait any longer for the MDR?
The discussions surrounding the MDR have very clearly demonstrated that there are no real regulatory gaps, even today. The issue is more a question of how clearly the law emphasizes the ”should“ and ”must” requirements and how these are interpreted and implemented by the individual bodies. Given this, the EU Commission already made an important step and issued a recommendation on the implementation of manufacturer audits, including unannounced audits, in September 2013. The recommendation aims at ensuring the consistent implementation of unannounced audits. After the experience of the PIP scandal, the recommendation particularly points out that Notified Bodies must check the coherence between the quantity of raw materials purchased and the quantity of finished products.
How do you assess the effectiveness of unannounced audits in improving patient safety?
In the past, the possibility to carry out unannounced audits had not been used consistently, as there had been no clear-cut requirements for their implementation, and the question of who had to pay for these audits had not been settled. In its recommendation, the EU Commission has now issued clear statements that leave less room for interpretation. Unannounced audits can be a powerful weapon in the battle against fraud and deceit, and the recommendation now gives Notified Bodies certainty over when and how to use this weapon. However, we must not forget that even the best surveillance cannot fully protect us against criminal activities.
For more current information relating unannounced audits please click here!