Plenary session endorsed essential measures that strengthen patient safety and improved the approaches on the approval system. The vote still leaves significant questions regarding the safety level for re-processing of medical devices. Overall, with this vote Parliament creates a good basis for constructive discussions and further improvements with Member States.
Brussels, 22 October 2013 – Eucomed, the European medical technology industry association, welcomes the majority of measures adopted today in a plenary vote by the European Parliament on the revision of the EU Medical Devices Directive (MDD). Members of the European Parliament (MEPs) have voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement.
On the approval system for medical devices, Eucomed positively notes that Parliament has shifted the approach and direction to a more manageable process without compromising the shared goal of improving patient safety. On the reprocessing of single-use medical devices, by adopting a variety of different elements, some newly introduced at Plenary, the approach taken still leaves significant concerns for patient safety as well as legal inconsistencies. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the European Parliament’s stated desire to install a high level of patient safety throughout Europe. All in all, Eucomed believes that this vote will send a strong signal towards Council that Parliament is interested in finding a balanced, implementable solution that guarantees both better patient safety and a vibrant and innovative MedTech sector.
Many measures pave the way to effectively improve the safety for patients and are fully supported by industry. Eucomed now believes that Council and Parliament can concentrate on further improvements, in particular on the medical device approval system, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances.
Industry holds the opinion that the Parliament has improved some very essential elements of the approval system, such as clarifying roles and responsibilities of authorities, the Medical Device Co-ordination Group (MDCG), and clinical experts; ensuring Member States authorities are managing the ‘scrutiny’ system, introducing the concept of utilising a small group from a pool of independent scientific experts to support the MDCG in their decision making and installing high-level expertise and quality amongst Notified Bodies. Eucomed believes that further improvements in the discussions with Council should look at building the scrutiny process into the upgraded notified body approval system and not adding it on top of or afterwards which would double or even triple the level of bureaucracy in an already improved system. Also, the scrutiny should avoid any sort of cherry-picking or random ‘needle-in-the-haystack’ approach. Eucomed also listened with interest to Commissioner Mimica’s comment in Plenary that after trust in the quality and competence in Notified Bodies has been built, a move could be feasible from a pre-market product scrutiny to a post-market system scrutiny based on post market controls.
MEPs also gave a strong signal on the reprocessing of single-use medical devices by not following the full ENVI proposal whereby medical devices such as syringes would be reusable by default. Unfortunately neither did they revert to the balanced Commission proposal. Instead they adopted a hybrid approach that still leaves significant concerns for patient safety. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the Parliament’s stated desire to install a high level of patient safety throughout Europe. Furthermore, in defining ‘single-use devices’ Parliament kept the practically un-implementable approach to legally and scientifically require manufacturers to prove the impossibility of reprocessing, which is an impossibility in itself. There are also other legal inconsistencies inherent in the adopted reprocessing text.
The next phase in the legislative process should tackle these and the more technical aspects, to ensure that all measures are appropriate, applicable and implementable for authorities and stakeholders. Top of the list here would be further improving the ‘scrutiny’ mechanism, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances.
“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council. We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices.” said Eucomed Chief Executive Officer Serge Bernasconi.
Niall MacAleenan, Clinical Assessment Manager, IMB, gave a very timely presentation to IMSTA members at our recent Business Breakfast on the implications of these regulations for distributors in Ireland. A copy of his presentation is below.