The European Regulations on Medical Devices including Active Implantable Medical Devices (AIMD), and In Vitro Diagnostic (IVD) Medical Devices have been officially published on May 5th, 2017. Both entered into force on May the 25th, 2017.
In addition to their major impact on Medical Device Manufacturers' responsibilities, they significantly modify the tasks of Notified Bodies such as LNE/G-MED. In order to maintain the confidence of Manufacturers whose medical devices we certify and guarantee the sustainability of our services, LNE/G-MED, together with its subsidiary G-MED North America Inc , has established a strategy to obtain its Designation as a Notified body under the new European Medical Device and In Vitro Diagnostic Regulations, which will enter into force in the near future.The European Regulations will be applicable in 2020 for Medical Devices (including the Active Implantable Medical Devices) and 2022 for In Vitro Diagnostic (IVD) medical devices.
A long-standing investment for an optimum control of the Regulation
In order to prepare ourselves for these deadlines, we focused our efforts on the knowledge and appropriation of the new Regulatory Requirements, starting our analysis as early as 2012, when the first draft texts were published. This strategy allowed us to identify the actions to be implemented in order to satisfy each requirement. In order to guarantee the efficiency of this approach, we entrusted a group of experienced LNE / G-MED employees with the management of this project, a group composed of individuals familiar with the responsibilities and tasks of the Notified Body, the applicable regulatory aspects as well as the performance of services for Medical Device manufacturers.
Our approach is supported by LNE/G-MED’s participation to several European initiatives, such as the work launched by TEAM NB (The European Association of Notified Bodies for Medical Devices) whose objective is the development of a common analysis of the new Regulations by Notified Bodies and a harmonized interpretation. LNE / G-MED is also very active within several working groups, meeting under the aegis of the European Commission or Competent Authorities.
The scope of the application for the designation under the new MDR and IVDR
As a Notified Body, we want to enable Medical Device manufacturers whose products are already certified by LNE/G-MED to continue answer the need of patients and users without any shortage in the supply of their products. To fulfill this objective, LNE / G-MED is requesting its designation as Notified Body for the areas currently under its responsibility:
Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices
LNE/G-MED’s application for designation also includes products without a medical destination, but concerned by the Regulations, allowing us to answer to the need of manufacturers developing these products and already certified by LNE / G-MED.
A structured action plan for the designation process
Our action plan is built around three main milestones:
The submission of applications for Authorization to the French competent authority ANSM,
• An on-site evaluation of LNE / G-MED by ANSM evaluators and evaluators appointed by the European Commission and the other Member States,
• Obtain the Designation, thus making it possible to initiate the realization of the services according to the new European regulations.
Each of the milestones is defined by different actions, such as the evolution of practices, the updating of our Quality System, and the training for those involved in the certification process.
The entry into force of the MD and IVD Regulations took place on May the 25th, 2017, with a transition period of 3 years for the Medical Devices including Active Implantable Medical Devices; and 5 years for In Vitro Diagnostic Medical Devices. From their application date, respectively 2020 for the Medical Device Regulation and 2022 for the In Vitro Diagnostic Regulation, LNE / G-MED will no longer be authorized to perform services and issue certificates according to the current applicable Medical Device Directives.
Certificates issued during the transitional period will have a validity period which cannot exceed 2024, irrespective of the Directive or conformity assessment procedure claimed by the manufacturer. Article 120 of the Medical Devices Regulation and Article 110 of the In Vitro Diagnostic Regulation describe each the transitional provisions applicable:
Medical Devices: Article 120 of the Regulation
In Vitro Medical Devices: Article 110 of the regulation
The Regulations anticipate that Notified Bodies will not be able to apply for their designation for the first 6 months following the date of entry into force of the Regulations. In order to anticipate the deadlines of 2020 and 2022, LNE / G-MED will file the application as soon as possible with ANSM, which would be before the end of the last semester of 2017.
The period between filing the application and obtaining the designation under both Regulations will be devoted to the preparation of the on-site assessment and the deployment of the modalities to perform the certification services in accordance with the scope of designation.
Our goal is to be one of the first organizations to be designated and therefore authorized to carry out evaluations and issue certificates of compliance with the requirements of the new MD and IVD Regulations. It is essential in order for us to accompany our customers in their transitional process for the products already on the market, for new designs or products not yet covered by European regulations.
Anticipating: a key step in our strategy to support the industry
The requirements of the European regulations will strongly impact the responsibilities of the manufacturers and the status of some of their products currently on the market: classification change, changes of the conformity assessment procedure, strengthening of the Clinical Evaluation and Post Market Surveillance (PMS) requirements.
Some products will now be subject to a conformity assessment by the Notified Body. The anticipation of these fundamental changes is one of the key steps in our strategy. Anticipating early on these differences will allow us to identify the number of manufacturers involved, to adapt the action plan and proceed with the transition and / or initiation phase as soon as we have obtained the designation as Notified Body in accordance with the new Medical Device and In Vitro Diagnostic Regulations.
We hope to enable Manufacturers to successfully undertake this regulatory transition and maintain their products in the medical and healthcare market.