We are there to support you in the various healthcare sectors including aesthetic applications…
Medical, In-Vitro Diagnostic and Combination device manufacturers are required to establish, document and implement a quality management system and to maintain its effectiveness throughout the life cycle of the devices concerned. To fulfill this obligation, the various manufacturers make use of internationally recognized standard i.e., ISO 13485. AKRA TEAM can help you identify any gaps related to your organization, your list of products and the applicable legal requirements. Moreover, we can support you implementing the relevant measures ensuring compliance.
The EU MDR 2017/745 was published on 25 May 2017 with a transition period of three years, which was changed to four years due to the worldwide pandemic COVID19 situation. This regulation includes higher quality management system expectations especially for class I device manufacturers, increased technical documentation content requirements, higher level of clinical evidence in the clinical evaluation and challenging post-market reporting obligations. Certificates issued by notified bodies in accordance with Directives90/385/EECand 93/42/EEC from 25 May 2017 will remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. Nevertheless, they
will become void at the latest on 27 May 2024. This mean that manufacturers are still allowed to place devices on the EU Market from 26 May 2021 by virtue of a valid certificate till latest 27 May 2024. With the corrigendum to Regulation in December 2019, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to the EU MDR requires the involvement of a notified body may also continue to be placed on the market till 26 May 2024. To be able to make use of this grace period (2021-2024), manufacturers are required to fulfill the specific prerequisites written in Article 120(3) of the regulation. AKRA TEAM can help you understanding the interpretation of this article of the regulation and fulfilling your legal obligations in a practical and reasonable way. Also from 26 May 2021, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC will become void. This additional legal text may impact your market continuity. Don´t wait further and get in contact with us! We can help you from the initial strategy to certification by mitigating your risk and increasing your certification success.
The EU IVDR 2017/746 was published on 25 May 2017 with a transition period of five years. This regulation includes higher quality management system, technical documentation, performance evaluation and post-market reporting requirements. The implementation of this regulation will lead to more devices which require the involvement of notified bodies during the conformity assessment process. Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 will become void by 27 May 2024. This mean that manufacturers are still allowed to place devices on the EU Market
from 26 May 2022 by virtue of a valid certificate till latest 27 May 2024. To be able to make use of this grace period (2022-2024), manufacturers are required to fulfill the specific prerequisites written in Article 110(3) of the regulation. AKRA TEAM can help you understanding the legal text of the regulation and fulfilling your legal obligations in a practical and reasonable way. Also, from 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC will also become void and the number of currently designated notified bodies for the EU IVDR is limited. This legal text and the limited available capacity at the notified bodies may impact your market continuity. Don´t wait further and get in contact with us! We can help you from the initial strategy to certification by mitigating your risk and increasing your certification success.
a. Article 117 of the EU MDR Medicinal products including a device fulfilling the medical device definition – With the EU MDR a new process was established regarding devices included in a medicinal product where the conformity assessment, if used separately, the involvement of a notified body is required. AKRA TEAM can help you understanding this requirement and preparing your supportive evidence showing compliance to the relevant general safety and performance requirements set out in Annex I of the regulation. We have a good relationship to EMA and the designated notified bodies, and can help you understanding their expectations.
b. Rule 14 of the EU MDR This classification rule of the EU MDR applies to all devices incorporating, as an integral part, a substance which, if used separately, may be considered to be a medicinal product with the meaning of Directive 2001/83/EC, including medicinal product derived from human blood or human plasma. This special rule increases the classification of the relevant device to the highest risk of the EU MDR – Class III. Under the old Directives, not every inclusion of a medicinal product led to a Class III classification since the liability of the substance to act on the human body was considered during the classification decision process. For devices falling under this rule, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC. This process is unknown for a lot of affected manufacturers. Also, the adopted consultation process related to the activities of the notified body to seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA is unclear. AKRA TEAM can help you preparing the relevant regulatory strategy, selecting the right notified body, planning a pre-submission meeting with a designated competent authority, preparing compliant documentation and submitting your CTD File in accordance with the applicable requirements