Since 26 May 2021 medical devices such as health apps, patches, ventilators, or pacemakers must comply with the Medical Devices Regulation (EU) 2017/745 (MDR) to continue to be placed on the Union market or put into service, unless transitional provisions apply (see Art. 120 MDR). The MDR does not convey any grandfathering. Before manufacturers can affix the CE marking to their medical devices and place them on the market within the European Union, they must, in principle, carry out a conformity assessment procedure to check whether the medical device complies with the various requirements of the MDR. However, these conformity assessment procedures are time-consuming in view of the more stringent requirements of the MDR. In addition, manufacturers - except of low-risk products in risk class I - must have recourse to so-called notified bodies such as TÜV Süd or DEKRA, of which there are currently far too few at the European level. The long waiting times and capacity bottlenecks at the Notified Bodies in combination with the generally increased demand for medical devices as a result of the COVID-19 pandemic and pandemic-related delays thus raise the question of the conditions under which manufacturers can exceptionally place their medical devices on the market, at least on German territory, even before completion of a conformity assessment procedure. The MDR provides two possibilities for this: On the one hand, a temporary exemption from the conformity assessment procedures can be granted in accordance with Art. 59 MDR. On the other hand, a temporary tolerance of non-conformity according to Art. 97 MDR can be considered.
Temporary exemption from the conformity assessment procedures according to Art. 59 MDR
According to Art. 59 (1) MDR, the BfArM may, in exceptional cases, authorize the placing on the market of medical devices for a limited period of time even without a conformity assessment procedure. It follows that the exception is basically of a temporary nature and limited to the territory of the Federal Republic of Germany. The basic prerequisite for such a special approval is that the use of the specific medical device is in the interest of public health or patient safety or health. Thus, the justification of the respective application is of elementary importance, which must substantiate why the completion of a conformity assessment procedure cannot be waited for. Furthermore, the application must show that there are no medically equivalent alternatives. In this respect, the opinion of a medical society can be helpful. The fact that chances of success of well-founded applications according to Art. 59 MDR are not merely theoretical, despite all the requirements, is shown by the approval practice of the BfArM. Since the MDR came into force, several medical devices with and without direct reference to the COVID-19 pandemic have already been approved for a limited period. We ourselves have already been able to obtain special approvals for various EU member states, including Germany, on the basis of Art. 59 MDR.
Temporary tolerance of non-conformity in accordance with Art. 97 MDR
In addition to the procedure at federal level, Art. 97 MDR offers the possibility for the market surveillance authorities responsible at the state level to temporarily tolerate the non-compliance of medical devices at the request of the manufacturer or another economic operator (e.g. importer). In this context, too, the application carries significant weight when it comes to demonstrating that the medical device in question does not present an unacceptable risk and that the manufacturer has made every effort possible to carry out a regular conformity assessment procedure. Although not all ambiguities have yet been cleared up at the national level with regard to the responsibility and scope of acquiescence, a look at the European level gives cause for optimism. In other member states, exemptions have already been granted in accordance with Art. 97 MDR. In Germany, however, it is problematic that the BfArM is not responsible, and therefore - especially if the manufacturer is based abroad - the question arises as to which German market surveillance authority can be contacted. Nevertheless, the work of the European Medical Devices Coordination Group and the Commission on Article 97 MDR indicates that a harmonized approach may be approaching.
