Special Approvals for Medical Devices

The Corona crisis shows the immense importance of an adequate supply of medical products to health care facilities and pharmacies. The demand for certain products, such as medical respiratory masks and respirators, has risen dramatically worldwide. Manufacturers of approved medical products were not able to satisfy the increased demand everywhere. So-called special approvals for medical devices represent a possible solution to impending bottlenecks. Under this special procedure, medical devices that have not yet undergone a conformity assessment procedure can be placed on the market ahead of time.

Legal basis: Art. 59 MDR

Until now, Art. 11 Para. 13 of the Medical Device Directive (MDD) and Section 11 of the Medical Devices Act (MPG) contained regulations for the application and approval of medical devices for which no conformity assessment procedure was carried out. In the Medical Device Regulation (MDR),  Art. 59 (exception of conformity assessment procedures) regulates the procedure for special approval.

With the Regulation amending the MDR (Amendment Regulation EU 2017/745 of April  23, 2020, hereinafter "Amendment Regulation"), the legislative bodies of the EU have reacted to the effects of the COVID-19 outbreak and, among other things, postponed the start of validity of the MDR by one year to May 26, 2021. An exception to this was Art. 59 MDR, which already applies. Section 11 MPG and the corresponding MDD regulations are therefore no longer relevant for special approvals applied for after April 24, 2020. Instead, the EU has opted for a uniform Union Regulation, particularly in view of the global COVID-19 crisis.

The adapted version of Art. 59 MDR provides for a two-stage system:

(i) First, the special approval must be applied for at the respective competent national authority. The application must be justified (see § 7 of the German Medical Devices Implementing Act (MPDG). If the authority grants the special approval and this is not limited to the use of a product for one patient, the authority informs the commission about the granted special approval. This also applies to special approvals granted by the national authority under the MDD regulations (supplemented by the respective national law).

(ii) The commission then decides on a possible temporary, Union-wide extension of the nationally granted special approval and the conditions for placing on the market and/or putting into service such products. Whereas the MDR previously provided that a Union-wide extension requires a special authorization granted under the MDR, the amended version of Article 59 of the MDR now provides that the commission may also justify the Union-wide extension on the basis of nationally granted authorizations previously granted under the MDD and the corresponding national law (in Germany, Section 11 of the MPG).

In particularly urgent cases, the commission can also act directly.

The provisions of the MDR are flanked by the so-called MPDG, which has not yet completely entered into force. According to Section 7 MPDG (which entered into force on April 24, 2020), the Federal Ministry of Health is authorized to issue further regulations on the approval procedure and the detailed requirements for the marketing of products with special approval by means of a statutory instrument.

If manufacturers of a medical device wish to apply for a special approval, we recommend contacting the authorities informally before submitting an application in order to coordinate the further procedure as well as the required documents and information on the medical device. According to the MPDG, the Federal Institute for Pharmaceuticals and Medical Products (BfArM) is still responsible for special approvals in Germany.

Conditions of the special approval

The basic requirement for a special approval is that the use of the medical device is in the interest of public health or patient safety or health. As special approvals deviate considerably from the strict and extensive approval procedure, this is an exceptional provision which only applies in emergency situations. According to the authors' knowledge, there were hardly any special approvals under the MPG until the outbreak of the Corona virus. Due to the current pandemic, the BfArM recently granted special approvals for medical mouth and nose protection (MNS) and filtering half masks (FFP2 and FFP3). For example, there must be such a health hazard that the medical product must be available on the market ahead of time in order to at least increase the chance of improved health protection. While the MDD "only" provided that the product can be authorized for exceptional approval in the interest of health protection, the MDR also takes up the issues of patient safety and patient health as possible justifications for special approval. The provision is therefore somewhat broader than the previous MDD regulation, so that patient-specific interests are also taken into account. Thus, it follows from Art. 59 para. 2 MDR that special authorizations can also be limited to the use of the product for a single patient. In this case, the commission will not be informed about the granted special approval. Nevertheless, even in view of this extension, nothing should change the fact that special authorizations and thus a rapid market introduction that bypasses the conformity assessment procedure can only be considered in exceptional cases.

Prospect

In view of the corona crisis, it can be assumed that more use will be made of the possibility of special approvals under Art. 59 MDR. In this context, we recommend contacting the BfArM before submitting an application, for example, in order to coordinate the actual product requirements. As the requirements for the conformity assessment of higher class medical devices will also become stricter with the entry into force of the MDR on May 26, 2021, the need for special approvals may also increase here. Particularly affected are cases in which specific products do not fulfil the MDR requirements in time (i.e. even after the transitional provisions have expired), but are in such a way in the interest of patient health that it is not possible to wait for the successful completion of the conformity assessment procedure.