MDR / IVDR
The two regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in-vitro diagnostics (IVDR) came into force on 25 May 2017. After a 3-year transition period for the MDR (26 May 2020) and a 5-year transition period for the IVDR (26 May 2022), the respective regulations become valid. The corresponding directives will for the most part be repealed on the date of validity of the Regulation - i.e. Directives 90/385/EEC and 93/42/EEC on 26 May 2020 and Directive 98/79/EC on 26 May 2022.
The regulations can be found on the following websites:
- Regulation (EU) 2017/745 on medical devices
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
The following corregendums were made to the Regulations:
- Corrigendum to Regulation (EU) 2017/745 concerning medical devices
- Corrigendum to Regulation (EU) 2017/746 on in vitro diagnostic medical devices
With regard to the transitional provisions in the regulations, FAQ documents have been prepared and published by the European authorities:
- Transitional provisions to Regulation (EU) 2017/745 on medical devices
- Transitional provisions to Regulation (EU) 2017/746 on in vitro diagnostic medical devices
For the implementation of the MDR and IVDR, a roadmap was developed and published by the European authorities in which work packages for the respective European working groups were formulated.
Further information on the MDR and IVDR is also available on the European Commission's website.
Information for manufacturers of Class I medical devices
An MDCG guidance note for Class I medical device manufacturers has been published on the website of the European Commission.
The document explains the necessary steps that manufacturers must follow to place such a medical device on the European market in accordance with the requirements of the MDR. This includes both the necessary procedures prior to market introduction and post-market surveillance.
Information on cybersecurity according to the MDR/IVDR
According to Annex I of the MDR/IVDR, manufacturers must meet a number of requirements to ensure that medical devices are fit for the new technological challenges linked to cybersecurity risks. A guide for manufacturers has been published on the website of the European Commission.
The document provides information on cybersecurity concepts, explains the related essential requirements and provides additional legal provisions to be considered.
Information on the summary of safety and clinical performance
Article 32 of the MDR requires manufacturers to prepare a summary of safety and clinical performance (SSCP) summary report for implantable and class III medical devices. This SSCP will be validated by a Notified Body and then uploaded to Eudamed. A document on the SCCP has been published on the website of the European Commission.
Specifically, the contents of the SSCP and the validation process are addressed. The document also contains a template for the SSCP.
Information on the qualification and classification of software according to MDR/IVDR
A document has been published on the website of the European Commission dealing with the qualification and classification of software as a medical device (MD) or in vitro diagnostic medical device (IVD).
The document contains information on the differentiation between software as MD/IVD, software for controlling MD/IVD and software as a component of MD/IVD. Furthermore, the document deals with the application of the classification rules in detail.
Information on the implementation of the implantation card in accordance with the MDR
Manufacturers of an implantable device must provide information for identification of the device in the form of an implantation pass (IA) in accordance with Article 18 MDR. On the website of the European Commission, more detailed descriptions for the uniform design of an IA have now been published.
In particular, those contents are described in more detail which must be made available by the manufacturer on the IA. Also included in this document is information on what content should be added by health care institutions.
Information on the person responsible for compliance with regulatory requirements according to MDR/IVDR
According to MDR/IVDR, manufacturers and authorised representatives must have a person responsible for regulatory compliance (PRRC). The requirements and responsibilities as well as the employment relationship of the PRRC are defined in Article 15 MDR/IVDR. A document has been published on the European Commission's website to clarify these requirements.
In particular, the document contains more detailed explanations on the relationship between the PRRC and the manufacturer or authorised representative - employment or contractual arrangement with an external company.
Information on the registration deadlines of products according to the MDR
According to Article 29 of the MDR, products must be registered in the electronic database (Eudamed). With regard to the deadlines for the registration of products, inconsistencies arise from the text of the MDR. A document clarifying the applicable time limits has been published on the European Commission's website.
Specifically, the transitional period for the registration of products referred to in Article 123(3)(e) is granted. However, full product registration remains a prerequisite for reporting serious incidents through Eudamed.
Information on the registration of guideline products in the electronic system (Eudamed) in accordance with the MDR / IVDR
Products in accordance with the guidelines (AIMDD, MDD, IVDD) can be placed on the market, made available on the market or put into operation under certain conditions even after the date of application of the respective regulation. Article 120, paragraph 3 of the MDR and Article 110, paragraph 3 of the IVDR provide, inter alia, that the registration of Directive products in Eudamed must be carried out in accordance with the relevant Regulation. A document has been published on the European Commission's website.
Specifically, there is no obligation to allocate a (basic) UDI-DI for guideline products. For this reason, Eudamed has been adapted to allow the registration of policy products without (basic) UDI-DI.
Interpretative document on consultation procedures according to Article 54 of the Medical Devices Ordinance (MDR)
Article 54 of the MDR regulates the consultation procedure relating to the clinical evaluation of certain devices in Class III and Class IIb. With regard to the exceptions to this procedure, an interpretative document has been published on the website of the European Commission.
Specifically, the interpretation of Article 54(2)(b) has been clarified. Under certain conditions, the derogation also applies to products which have already been placed on the market in accordance with the Directives.