Medical Device Regulation – Regulatory aspects
You've probably heard that after years of discussion, the European Medical Devices Regulation has been reviewed and was adopted on May 2017. Therefore the safety, quality and performance of medical devices destined for the EU market are now subject to new, more rigorous regulations that have entered into force.
New regulation on medical devices – key aspects
Medical Device Regulation (EU) 2017/745 (hereinafter: MDR) applies since 26.05.2021, thus replacing Directive 93/42/EEC (hereinafter: MDD) which has been in force so far. The main aims of MDR are establishing high quality standards for medical devices, harmonising the rules concerning placing medical devices on the markets and effective supervision across European Union. Let’s not hide that changes in legislation were needed to reflect progress over the last 20 years.
So, the MDR retain the existing principles and basic elements of the regulatory system that has been functioning so far, but each element is strengthened and better defined. Among them are:
- improved performance of notified bodies,
- clearer requirements for clinical data and their assessment,
- reclassification of devices according to risk, contact duration and invasiveness,
- implementation of unique device identification,
- introduction of EUDAMED,
- rigorous post-marketing oversight.
What are the transition periods, what is the EUDAMED database and does it already affect the existing requirements of the Polish Agency in terms of informing it about placing products on the market? Let's check it.
Most of MDR’s obligations have applied from 26.05.2021, however to ensure the smooth transition to new requirements and to avoid any market disruption, the transition periods have been granted, associated mainly with UDI (Unique Device Identifier) carrier and Declarations of Conformity. The UDI identifier has to be placed by the manufactures in the following deadlines:
- 26.05.2021 for class III devices,
- 26.05.2023 for class IIa devices and class IIb devices,
- 26.05.2025 for class I devices.
Transition periods apply also for products fulfilling the below conditions:
- class I devices with Declaration of Conformity which was issued before 26.05.2021 and for which the conformity assessment procedure according to MDR provisions requires assessment by the notified body, can be placed on the market till 26.05.2024, if from 26.05.2021 devices have remained compliant with MDD and no significant changes in their design and application are foreseen.
- medical devices with certificates issued by notified bodies after 25.05.2017 can be placed on the market till 26.05.2024, if from 26.05.2021 devices have remained compliant with MDD and there are no significant changes to the design and intended use. As a rule, certificates issued by notified bodies before 25.05.2017 remain valid until the end of the period indicated in the certificate.
- medical devices which were lawfully placed on the market under MDD before 25.05.2021 can be placed till 26.05.2025.
EUDAMED - EU database on medical device
From regulatory point of view, very important change is introduction of a comprehensive EU database on medical device – EUDAMED, which is the key point of the MDR. The database will be composed of different systems which will allow to collect and manage information about medical devices and related companies (e.g. manufacturers, authorised representatives)
EUDAMED will consist of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
Currently, only one module of EUDAMED is functional – actor registration - and according to article 123 point 3 of MDR the registration in EUDAMED will be obligatory six months after publication of the information about fully operating of the database.
However, the company with a place of residence or registered office in the territory of Poland, which, in accordance with art. 31 sec. 1 of MDR, voluntarily submitted the required information for registration to EUDAMED system, should submit a letter to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (hereinafter: URPL) confirming the submission of the above-mentioned entry for a unique registration number.
Notifications of placing medical devices on Polish market in view of MDR
The notification of placing medical devices on Polish market should be still in accordance with Act of May 20, 2010 on medical devices. The manufacturer and the authorized representative with the place of residence in Poland shall notify the President of the Office at least 14 days before placing the first product on the market. A distributor and importer with a place of residence in Poland who introduced into the territory of Poland a product intended for use in this territory shall notify the President of the Office of this within 7 days from the date of introduction of the first product on the territory of the Republic of Poland. The detailed information on the documentation is available on URPL website.
As you can see, MDR imposes many new obligations on companies in the context of medical devices. However, we should not perceive the new regulation as a restriction, but as a way to ensure high quality standards and safety of patients, which in the long-term perspective can be beneficial for all of us.
To our Client we offer support at Pre-authorisation services, Handling of the registration process and Post-authorisation issues. More informations about Regulatory Affairs you can find here.
Would you like to register your medical device in Poland and need support at registration process? Our experts will be happy to answer all your questions. Do not hesistate contact us.
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