FILE DOWNLOAD:     (357.5K)  

1. Introduction In the context of the current COVID-19 global outbreak as well as the rapid spread of the virus across various regions of the globe, the resulting travel and quarantine restrictions have significantly affected the ability of notified bodies to conduct mandatory on-site audits under the medical devices legislation. Therefore, in the interest of public health, this document has been developed to outline temporary extraordinary measures for notified bodies to follow in this interim period in order to allow continued availability of safe medical devices to the market and assist in the prevention of the risk of medical device shortages. In this context, it is considered that alternative solutions to carrying out on-site audits by notified bodies under the medical devices Directives1 should be allowed under specific circumstances, including the possibility to perform remote audits under certain conditions. This guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. [생략]

FILE DOWNLOAD:     (1.0M)  

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD1 1 Introduction Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) states that devices which have a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024. [생략]

FILE DOWNLOAD:     (898.9K)  

How can affected manufacturers of some class I devices1 make efficient use of the transitional provisions in Article 120 (3) and (4) of Regulation (EU) 2017/745 – Medical Devices Regulation (MDR)? Background: The corrected MDR2 Article 120 (3) allows under certain conditions, some class I devices pursuant to Directive 93/42/EEC – Medical Devices Directive (MDD), for which the Declaration of Conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to the MDR would require the involvement of a notified body, to be placed on the market3 until 26 May 20244. In order to make use of this article, the following conditions must be met: 1. The device continues to comply with Directive 93/42/EEC, 2. A notified body will need to be involved under the MDR (e.g. re-usable surgical instruments or up-classified devices) 3. A valid Declaration of Conformity, according to Annex VII of the MDD, must be drawn up before 26 May 2020, 4. No significant changes to the design or intended purpose of the device after 26 May 20205, 5. The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in Directive 93/42/EEC.6 This shall be in place on the 26 May 2020. [생략]

FILE DOWNLOAD:  

파일 참조

FILE DOWNLOAD:     (1.8M)  

1. Introduction 1.1. Background The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereafter called the Medical Devices Regulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which are to replace three EU Directives1, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. Among the many novelties introduced, the two Regulations enhance the focus of legislators on ensuring that devices placed on the EU market are fit for the new technological challenges linked to cybersecurity risks. In this respect, the new texts lay down certain new essential safety requirements for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves. They require manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out minimum requirements concerning IT security measures, including protection against unauthorised access. [생략]