Abstract
The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.
Highlights
Due to safety issues in the field of medical devices, and especially after the Poly Implant Prothése (PIP) scandal in France, the Medical Device Directive (MDD) 93/42/EEC [1] was revised and replaced with the new Medical Device Regulation (MDR [European Union (EU)]) 2017/745 [2,3]
The MDR entered into force on May 25, 2017 and must be implemented within the European Union (EU) and European Economic Area (EEA) states after 3 years, by May 26, 2020 [2]
This contrasts with the previous MDD, which was a directive that member states transpose into national law within a set timeframe [4]
Summary
Due to safety issues in the field of medical devices, and especially after the Poly Implant Prothése (PIP) scandal in France, the Medical Device Directive (MDD) 93/42/EEC [1] was revised and replaced with the new Medical Device Regulation (MDR [EU]) 2017/745 [2,3]. Since the MDR is a regulation, it is immediately enforceable as law in all member states after its implementation date. This contrasts with the previous MDD, which was a directive that member states transpose into national law within a set timeframe [4]. Unlike the US Food & Drug Administration, which regulates foods, medicines, and medical devices, the European Medicines Agency (EMA) regulates only drugs. Manufacturers themselves declare conformity of their devices with the European legislations and regulations and affix a CE (Communauté europeénne) mark (Article 10 and 20 MDR). Products that bear a CE mark can be marketed within the EU/EEA (Articles 2 and 10 MDR). Affixing the CE mark to a product is only legal after a conformity assessment has been http://mhealth.jmir.org/2020/6/e17567/
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
