As of 2021-05-26, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) are history. These two directives are replaced by the European Regulation (EU) 2

017/745 (MDR). There will no longer be notified bodies notified under MDD or AIMDD, and declarations of conformity can only be issued under the new MDR. Due to the nature of the Medica

l Device Regulation (MDR) and its publication as a European Regulation, it is directly applicable European law and does not requir

e further implementation into national law. This means that national laws – especially medical device act – must be adapted accordingly and implemented by this deadline.

Situation in Germany:

In Germany, the Medizinproduktegesetz (MPG) will be replaced by the Medizinprodukte-Durchführungsgesetz (MPDG), published as part of the Medizinprodukte-EU-Anpassungsgesetz (MPEUAnpG) for products covered by the European Regulation (EU) 2017/745. For in-vitro diagnostics, the MPG remains valid.

The MPDG defines in particular national procedures such as national reporting obligations, procedures for the classification of products as well as the national possibility of special approvals, custom-made and adapted products but also procedures in the event of the termination of a manufacturer’s business activities. Other specific requirements relate to the operation of products as well as national penal provisions in the event of violations of the regulation. A separate chapter (Chapter 3, §§ 17 to 23) deals with notified bodies or testing laboratories. However, the largest part of the MPDG deals with the requirements for clinical trials and the products used (Chapter 4, §§ 24 to 70). Likewise, national requirements for incident reporting and market surveillance that go beyond the specifications and timelines of the MDR are specified in more detail (Chapter 5, §§ 71 to 82). The exclusively national requirements for medical device advisors (Medizinprodukteberater) continue to be regulated in the MPDG. At this point, it should be noted that some national ordinances are also being adapted accordingly. The adaptations are very different; while the Medical Device Operator Ordinance (MPBetreibVO) is primarily adapted to the underlying act, the Medical Device Safety Plan Ordinance (MPSV) is replaced by the new Medical Device User Notification and Information Ordinance (MPAMIV). An adaptation necessary due to the new definition of reporting obligations in the MDR.

Situation in Austria:

In Austria, the Medical Devices Act (MPG) will also be published in the form of the MPG 2021. A first draft is already available.

The adjustments are necessary in particular to adapt the respective national MPG to the new, legally binding specifications at the European level in the form of the MDR or IVDR.

Situation in Switzerland:

The situation in Switzerland is significantly more complex. Since Switzerland is not a member state of the European Union, it must be regarded a priori as a third country. Until now, there have been Mutual Recognition Agreements between the EU and Switzerland, which guaranteed uniform market access for medical devices. However, the currently existing agreements refer to the European directives (AIMDD, MDD and IVDD); the new regulations (MDR and IVDR) are currently not covered.

According to the Swiss Medical Technology Association, a timely political agreement is currently not assured. In preparation for this, Switzerland has prepared the new Swiss Medical Devices Ordinance (Eventual-MepV). For the Swiss medical device industry, this means major changes for both exports and imports. For example, manufacturers from Switzerland must meet the requirements of a third-country manufacturer in order to be allowed to place products to the EU market under the MDR. This includes e.g. the designation of a European Authorized Representative and the appropriate labeling. Certainly, these requirements apply to products under the MDR as well as all Class I productsdevices. At present, however, it cannot be excluded that this will also apply to products marketed under a valid MDD certificate.

Also when exporting products to Switzerland, importers must meet the requirements of the Swiss Medical Devices Ordinance (Eventual-MepV) in order to be able to place products on the Swiss market. This essentially includes the designation of a Swiss Authorized Representative by the manufacturer and the corresponding labeling – transition periods are graduated according to the risk class, starting with the end of 2021. Furthermore, national registration and notification obligations or obligations for the Swiss Authorized Representative and the provision of the SSCP will need to be fulfilled.

It should be noted that due to the longer transition periods, Directive 98/79/EC (IVDD) and – exclusively for in vitro diagnostic medical devices – also the current Medical Devices Act will remain applicable law until 2022-05-26.