They rekindled debate over the safety and transparency of medical devices and also triggered changes on an international level. As a result, new laws are needed more than ever. In this MEDICA.de interview, Manfred Kindler, a publically appointed and sworn medical technology expert, explains the fundamental issues with the MDD and how they need to be counteracted on an international level.
Mr. Kindler, can you outline the Medical Devices Directive?
Manfred Kindler: The legal foundation for the German Medical Devices Directive with three European guidelines on active implants, medical devices and in vitro diagnostic products was established 20 years ago. These apply in the EU member states ever since they have been implemented into domestic law and were included in the Medical Devices Directive (MDD) in 1994 in Germany. The MDD established a monitoring and reporting system that works closely with comparable systems by the other member states.
The identifying feature for the commercial viability of the medical devices is the CE mark that is added to the outside of the device and/or the packaging. The registration office, the so-called ‘notified body‘ needs to determine compliance with EU directives and award the CE mark to devices that are assigned to a higher risk category based on regulatory classes. The manufacturer can certify medical devices with the lowest risk on his or her own.
Why was this law introduced and what is its primary objective?
Kindler: The purpose of the MDD is to regulate medical devices and thus ensure safety, suitability and performance as well as the health and necessary protection for patients, operators and third parties. The MDD determines that devices can only be put on the market and into operation if they are medically and technically unobjectionable, exhibit the quality required for health protection and maintain it during the entire product lifecycle and its application. It therefore is aimed at two large target groups: manufacturers and importers on the one hand as well as users and operators on the other.
Can the guidelines be efficiently and comprehensively implemented throughout Europe?
Kindler: In practice, frequently imported medical devices unjustifiably carry the CE mark. Given the high level of innovation and the short trial phases of new technologies and materials, serious side effects in everyday use are not discovered until after the market launch. What’s more, the previous monitoring system was not able to uncover fraud in time, as was the case with the breast implants filled with industrial silicone oil.
There are many reasons for this and they have been known for a long time: non-European manufacturers don’t study EU regulations sufficiently, are not competent enough to ensure proper implementation or want to "make a quick buck". Market supervisory authorities are often severally understaffed, are often also technically overwhelmed by the complexity and are under political pressure due to consideration for domestic export products. The more than 80 typically private notified bodies in Europe have different levels of staffing and competence, are under severe competitive pressure and tend to grant courtesy certificates based on potential conflict of interests due to manufacturer commissioning.
What are the problems with this directive from the manufacturer’s point of view?
Kindler: The manufacturer categorically needs to establish a quality management system and submit extensive technical documentation for his device, which includes a risk and clinical assessment. In many reviewed cases, it was questionable whether the manufacturers had expertly performed the required risk analyses and clinical assessments. After all, it’s not just non-European manufacturers that have a hard time assessing or documenting the required specifications for inspection and maintenance.
There are problems when combining the systems of different manufacturers. Even though all components have a CE mark, it is not guaranteed whether a combination a user desires can be safely operated. The hospitals and users therefore complain about a lack of feedback from responsible state authorities and feel neglected by them.
Kindler: There are already intense negotiations in this area: the current controversial public debate about the free trade agreement between the European Union and the United States, the Transatlantic Trade and Investment Partnership – TTIP). It aims at far-reaching trade liberalization for all economic sectors that are not explicitly excluded. Aside from emergency rescue services, this also includes the public health sector. This ultimately means that companies from other FTA partner countries need to be granted the same market access as domestic companies. Thanks to its strong export orientation, German medical technology could particularly benefit from the TTIP.
The International Medical Device Regulators Forum (IMDRF) is another platform. It was drawn up in February of 2011 by a voluntary group of medical regulators from Australia, Brazil, Canada, China, the European Union, Japan and the United States as a forum to harmonize the future direction in medical technology regulation. The IMDRF just issued a guideline that tries to derive a classification matrix for risks based on "software as a medical device".
Another IMDRF project deals with harmonizing the various approval processes and meeting the national regulatory requirements. It developed a new certification program for this, the MDSAP (Medical Device Single Audit Program). A joint auditing standard is intended to make it possible for medical device manufacturers to have their quality management systems audited once a year by a MDSAP-approved auditing organization, in due consideration of the respective regulatory requirements of domestic regulatory authorities.
Additionally, by introducing the Unique Device Identification (UDI) system as well as ensuring the compatibility of European and US databases, global traceability of medical devices is meant to be enhanced.
The European Commission also wants to standardize electronic approval applications thanks to TTIP and therefore reduce additional administrative work for manufacturers and public authorities. However, a successful implementation of these objectives requires the European Union to finally pass the new Medical Devices Directive.