Regulatory
manufacturers as they may result in a classification change for some devices, according to their risk, contact duration and invasiveness. In particular, Class III and implantable devices will have higher clinical requirements and be subject to a regular scrutiny process. MDR also introduces a new classification, Class Ir, for reusable surgical devices. Unlike other Class I devices, Class Ir devices require notified body involvement.
Furthermore, there are no ‘grandfathering’ provisions in MDR. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements. This ties in with increased regulatory expectations for clinical evaluation. MDR requires that manufacturers conduct clinical investigations to demonstrate their products’ compliance with Annex I. It is important to note that for legacy devices, manufacturers must conduct a comprehensive gap assessment against Annex I and identify if there are any gaps in the clinical data for their device that may prevent recertification. Under MDR, manufacturers must also conduct post-market clinical follow-up (PMCF) and, using the data collected, update the clinical evaluation for the device. The data and information derived from the PMCF must also be entered on EUDAMED. Acknowledging the advances in the development and use of software for activities such as patient monitoring, MDR’s Rule 11 specifically focuses on the classification of software dependent on its intended use. Many software applications that were regulated as Class I under MDD are now Class II or higher under MDR.
Another important change under Article 15 of MDR is the requirement for a ‘person responsible for regulatory compliance’ (PRRC). The PRRC is employed by either the manufacturer, or, in the case of manufacturers based outside the EU, its authorised
Key dates for MDR implementation
■ 26 May 2021: Date the EU MDR became legally binding. The original 2020 deadline for application was delayed due to the coronavirus pandemic.
■ 26 May 2022: Earliest date EUDAMED is estimated to go live. The European Commission will make some EUDAMED modules available in 2021 but decided to delay its full application.
■ 26 May 2024: Certificates issued under MDD become void. This is the last date for placing medical devices on the market unless they meet MDR requirements. Thus, notified body certificates issued under MDD designation become void (if not already expired).
■ 26 May 2025: Last possible date for putting devices into service according to MDD. After this point, end-users (hospitals, for instance) can no longer put MDD products into service.
representative, and has very specific responsibilities. These include ensuring that unacceptable or defective devices are not released to the market, and that post market surveillance and vigilance reporting requirements are fulfilled. MDR imposes strict educational and experience requirements on each PRRC in respect of the importance of the role in safeguarding regulatory compliance. The introduction of a full unique device identification (UDI) system for better traceability and recall is a key MDR addition, but a lack of clarity about how manufacturers should implement it has caused issues. There is still confusion around how labelling and packaging should incorporate UDI information, especially if the manufacturer’s target markets are international and cover different regulatory jurisdictions. Within Europe, as a result of the postponement of a number of its modules, the use of EUDAMED will be limited until 2022, further hampering some UDI operations.
The price of preparation
OEMs and the wider medtech industry have had the opportunity to review MDR and its impact since it was published. In principle, it could have been adopted by manufacturers of medical devices
Gabriel Adusei, associate director, Guidehouse Europe
Dr Gabriel Adusei has over 30 years of experience in the medical device industry, with periods in research and academia. He is acknowledged as a thought leader, having worked on many high-profi le projects in the medical device technology industry in different capacities, and his numerous publications have also infl uenced recent industry developments.
Medical Device Developments /
www.nsmedicaldevices.com
21
symbiot/
Shutterstock.com
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