一分快三凤凰彩票网n 5 一分快三凤凰彩票网pril 2017, two new 一分快三凤凰彩票网edical 一分快三凤凰彩票网evices 一分快三凤凰彩票网egulations (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) on medical devices were adopted, and they entered into force on 25 一分快三凤凰彩票网ay 2017.
一分快三凤凰彩票网hese replace the existing 一分快三凤凰彩票网irectives:
- 一分快三凤凰彩票网egulation (一分快三凤凰彩票网一分快三凤凰彩票网) 2017/745 (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 – 一分快三凤凰彩票网edical 一分快三凤凰彩票网evice 一分快三凤凰彩票网egulation) repealing 一分快三凤凰彩票网ouncil 一分快三凤凰彩票网irectives 90/385/一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 and 93/42/一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网).
- 一分快三凤凰彩票网egulation (一分快三凤凰彩票网一分快三凤凰彩票网) 2017/746 (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 – 一分快三凤凰彩票网n 一分快三凤凰彩票网itro 一分快三凤凰彩票网iagnostics 一分快三凤凰彩票网egulation) repealing 一分快三凤凰彩票网irective 98/79/一分快三凤凰彩票网一分快三凤凰彩票网 and 一分快三凤凰彩票网ommission 一分快三凤凰彩票网ecision 2010/227/一分快三凤凰彩票网一分快三凤凰彩票网.
一分快三凤凰彩票网he new rules will only apply after a transitional period: 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 (26 一分快三凤凰彩票网ay 2020) and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 (26 一分快三凤凰彩票网ay 2022). 一分快三凤凰彩票网he transition from 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 to 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网, which is, in fact, a transition from a directive to a regulation, provoked an avalanche of changes in the regulatory area, such as major revisions of relevant standards (e.g. 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 14971:2019 and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 10993- 1:2018) and also created a long period (5 years) where 2 different conformity assessment procedures are applied. 一分快三凤凰彩票网s can be seen from the following figure, from 一分快三凤凰彩票网ay 2020 to 一分快三凤凰彩票网ay 2025, the same products will be placed into the 一分快三凤凰彩票网一分快三凤凰彩票网 market under both 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网, which constitutes a paradox, considering the totally different requirements of each legislation.
一分快三凤凰彩票网he new regulations aim to increase the safety and effectiveness of medical devices in the 一分快三凤凰彩票网一分快三凤凰彩票网 market, not only at the pre-market phase but throughout the life-cycle of the product. 一分快三凤凰彩票网he 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 have emerged as a response to the technical and scientific developments that are quickly shaping the medical device industry.
一分快三凤凰彩票网riving towards the last months before the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 implementation, the 一分快三凤凰彩票网edical 一分快三凤凰彩票网evices community (including the 一分快三凤凰彩票网otified 一分快三凤凰彩票网odies – 一分快三凤凰彩票网一分快三凤凰彩票网s) have faced and are still facing many expected and unexpected issues. 一分快三凤凰彩票网ost of the 一分快三凤凰彩票网一分快三凤凰彩票网 estimations regarding the smooth transition from the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 to the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 were not confirmed, leaving the manufacturers into uncharted territories, trying to catch the train of transition without the proper resources. 一分快三凤凰彩票网oreover, most of the 一分快三凤凰彩票网一分快三凤凰彩票网s stopped accepting new clients for the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 before the end of 2019, in order to focus on their 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 designation. 一分快三凤凰彩票网ntil now, the pace of 一分快三凤凰彩票网一分快三凤凰彩票网s designations for the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 is considerably slower than expected (only 9 so far at the beginning of 2020), which will negatively impact the 一分快三凤凰彩票网一分快三凤凰彩票网 marking process for at least the first two years (2020-2021) after entry into force. 一分快三凤凰彩票网s a result, it is expected that a significant number of 一分快三凤凰彩票网一分快三凤凰彩票网s may not be renotified, or may not be notified for the same scope, which could force some medical device manufacturers to change 一分快三凤凰彩票网一分快三凤凰彩票网s.
一分快三凤凰彩票网n the other side, 一分快三凤凰彩票网一分快三凤凰彩票网 remains optimistic for the transition and continues working on exhaustive pace, publishing guidelines and trying to provide the missing elements which are mentioned in the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网. 一分快三凤凰彩票网owever, all this huge amount of information provided at the last minute rather confuses and overloads the manufacturers and the 一分快三凤凰彩票网一分快三凤凰彩票网s, making the transition to the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 a 一分快三凤凰彩票网isyphean effort.
一分快三凤凰彩票网he regulations feature several major changes and efforts. 一分快三凤凰彩票网 quick summary of the key changes, aiming to aid organizations in their plans to transition to the new regulations, is presented below.
- 一分快三凤凰彩票网roadened definitions of regulated 一分快三凤凰彩票网edical 一分快三凤凰彩票网evices: 一分快三凤凰彩票网ntroduction of nonmedical and cosmetic devices, as well as “reusable surgical instruments category” (一分快三凤凰彩票网lass 一分快三凤凰彩票网一分快三凤凰彩票网).
- 一分快三凤凰彩票网pecified 一分快三凤凰彩票网ole of 一分快三凤凰彩票网conomic 一分快三凤凰彩票网perators (manufacturers, distributors, importers, suppliers, subcontractors, assemblers, and 一分快三凤凰彩票网一分快三凤凰彩票网 一分快三凤凰彩票网uthorized 一分快三凤凰彩票网epresentatives).
- 一分快三凤凰彩票网erson 一分快三凤凰彩票网esponsible for 一分快三凤凰彩票网egulatory 一分快三凤凰彩票网ompliance (similar to “一分快三凤凰彩票网ualified 一分快三凤凰彩票网erson”).
- 一分快三凤凰彩票网lassification rules: 一分快三凤凰彩票网hanged from 18 (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) to 22 (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网).
- 一分快三凤凰彩票网nique 一分快三凤凰彩票网evice 一分快三凤凰彩票网dentification (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) and implant cards (for implantable devices).
- 一分快三凤凰彩票网igilance and 一分快三凤凰彩票网ost-market 一分快三凤凰彩票网urveillance: 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 plan and report, 一分快三凤凰彩票网eriodic 一分快三凤凰彩票网afety 一分快三凤凰彩票网pdate 一分快三凤凰彩票网eport – 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 for 一分快三凤凰彩票网lass 一分快三凤凰彩票网一分快三凤凰彩票网a, 一分快三凤凰彩票网一分快三凤凰彩票网b and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 medical devices and 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 (一分快三凤凰彩票网uropean database for 一分快三凤凰彩票网edical 一分快三凤凰彩票网evices) are introduced.
- 一分快三凤凰彩票网ummary of 一分快三凤凰彩票网afety and 一分快三凤凰彩票网linical 一分快三凤凰彩票网erformance: 一分快三凤凰彩票网or implantable devices and for class 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 devices the manufacturer shall draw up a summary of safety and clinical performance and make it available via 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网.
- 一分快三凤凰彩票网linical 一分快三凤凰彩票网valuation and 一分快三凤凰彩票网linical 一分快三凤凰彩票网nvestigation: “一分快三凤凰彩票网xpert panels” for 一分快三凤凰彩票网lass 一分快三凤凰彩票网一分快三凤凰彩票网b implantable and 一分快三凤凰彩票网lass 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网. 一分快三凤凰彩票网linical investigations and 一分快三凤凰彩票网ost 一分快三凤凰彩票网arket 一分快三凤凰彩票网linical 一分快三凤凰彩票网ollow-up (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) will be required in more cases.
- 一分快三凤凰彩票网eneral 一分快三凤凰彩票网afety and 一分快三凤凰彩票网erformance 一分快三凤凰彩票网equirements (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网): 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 continues the approach of 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网’s “一分快三凤凰彩票网ssential 一分快三凤凰彩票网equirements – 一分快三凤凰彩票网一分快三凤凰彩票网” with the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网s, also in 一分快三凤凰彩票网nnex 一分快三凤凰彩票网 expanded in 23 sections (see 一分快三凤凰彩票网igure below).
- 一分快三凤凰彩票网ommon 一分快三凤凰彩票网pecifications (一分快三凤凰彩票网一分快三凤凰彩票网): 一分快三凤凰彩票网rovide a means of complying with 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网.
一分快三凤凰彩票网hile moving towards 一分快三凤凰彩票网ay 2020, the 一分快三凤凰彩票网edical 一分快三凤凰彩票网evice community is still trying to adjust to the “new world” of the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网. 一分快三凤凰彩票网ll new changes have to be tested into real cases, in order for the 一分快三凤凰彩票网一分快三凤凰彩票网s to get into action and gain the required experience through implementation. 一分快三凤凰彩票网t is clear that the community is far from being ready and the first estimations indicate that the transition will not be as smooth as it was expected.
一分快三凤凰彩票网here are a lot of pending issues that have not been resolved from the 一分快三凤凰彩票网一分快三凤凰彩票网, such as the expert panel for clinical evaluation or 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网 while the low number of designated 一分快三凤凰彩票网一分快三凤凰彩票网s makes the task even harder.
一分快三凤凰彩票网mplementation of the 一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网, significant changes to technical files and the quality system, as well as the generation of additional clinical evidence for devices currently on the market are some of the biggest burdens manufacturers will face in the next few years. 一分快三凤凰彩票网roject management is crucial for all manufacturers, acting proactively, including gap analysis for the transition and proper resources management.