Similarly as recently in the case of medical products, when on 9 February 2019 came into effect Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, a new EU legislation substantially modifying the medical device regulation will also soon come into force (become applicable).
The new legislation is the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“MDR”), which will become applicable (come into force) on 26 May 2020.
The MDR aims to ensure the smooth functioning of the internal market for medical devices and assure the high level of protection patient’s health, it also takes into consideration small and medium firm working in this sector. Furthermore, the issue of ensuring the safety and quality of medical devices is emphasized. Strengthening the basic elements underpinning existing legislation (vigilance, market surveillance, clinical investigations and clinical evaluation), while ensuring the transparency and traceability of medical devices, should help to achieve these objectives.
Active implantable medical devices and other medical devices were historically regulated by two different directives, Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (,,AIMDD”) and Directive 93/42/EEC of 14 June 1993 concerning medical devices (,,MDD”), which were transposed to the Czech legislation. The two directives, which have already undergone several amendments, should now be replaced by the MDR which will be applicable to all medical devices except in vitro diagnostic medical devices.
What specific changes does MDR bring?
Information provided by the manufacturer
MDR specifies particular requirements regarding the information supplied by the manufacturer of medical device to persons, who further dispose the medical devices. The new legislation should be stricter to ensure the correct and safer use of medical devices.
Each medical device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person. The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular medical device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s).
Furthermore, it is important to mention that the information required on the label shall be provided on the medical device itself. If this is not practicable or appropriate, some or all the information may appear on the packaging for each unit, and/or on the packaging of multiple devices. Instructions for use shall be provided together with medical devices, also in non-paper format (e.g. electronic). By way of exception, instructions for use should not be required for class I and IIa of medical devices.
For manufacturers who are not established in the EU, the authorized representative plays a crucial role. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the EU market if the manufacturer designates a sole authorized representative. His main role is to ensure the compliance of the medical devices produced by those manufacturers and to serve as their contact person established in the EU. The authorized representative shall be appointed by a mandate which has to be accepted in writing by him and shall be effective at least for all medical devices of the same generic device group.
In addition to the aforesaid, the identification of the medical device must newly include the identification of the authorized representative. Information about the authorized representative shall be directly available to everyone on the packaging or label of the medical device. A problem may arise in the event of a change of authorized representative, when the packaging or labels of medical devices will need to be changed and they must be provided with new identification data of the new authorized representative, which may lead to unnecessary increased costs. At the same time, it cannot be ensured that, even after authorized representative’s mandate has ended, users will not contact the former authorized representative with complaints and reports of suspected adverse events related to the medical device on which they are listed as an authorized representative. The original authorized representative will still be obliged to transmit the above-mentioned reports and complaints to the manufacturer or to the new authorized representative.
Medical device identification
MDR newly introduces Unique Device Identification system, so called UDI. The Unique Device Identification system is formed of:
1. Unique device identification which consists of two parts:
i. UDI device identifier (UDI-DI) specific to a manufacturer and a medical device, providing access to the information laid down in Part B of Annex VI of MDR; and
ii. UDI production identifier (UDI-PI) that identifies the unit of medical device production and if applicable the packaged medical devices, as specified in Part C of Annex VI of MDR;
2. placing of the UDI on the label of the device or on its packaging;
3. storage of the UDI by economic operators, health institutions and healthcare professionals, and
4. establishment of an electronic system for Unique Device Identification.
Unique Device Identifier (UDI) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. UDI is intended to help identify and facilitate the traceability of resources, with the exception of custom-made devices and devices that are the subject of clinical trials. Further requirements for the information to be provided when registering medical devices or the basic data to be entered in the UDI database are specified in Annex VI of MDR. In general, a unique identifier should be indicated on the label of each medical device on its packaging or label, etc. This change will obviously also lead the manufacturer to the obligation to update medical device labels or packaging to meet the above criteria and include a unique identifier.
What will happened with medical devices placed on the market before the date of applicability of MDR?
Generally, medical devices placed on the market after the applicability of MDR must already comply with MDR and meet all its requirements.
According to the transitional provisions of Article 120 of MDR, any publication of a notice for a notified body in accordance with AIMDD and MDD shall cease to apply from the date of application of the MDR. According to the transitional provisions of the MDR, some certificates issued by notified bodies remain valid until the end of the validity period indicated on the certificate.
The application of MDR transitional provisions to specific medical devices depends on the validity of the above-mentioned certificates, which is not the same for all medical devices (certificates), but it expires on 27 May 2025 at latest. It is therefore necessary to apply the transitional provisions cautiously to individual medical devices and situations.
Transitional provisions however provide for certain exceptions when they allow medical devices that meet the conditions of the old (existing) legislation to be placed on the market for a fixed period of time, i.e. AIMDD and MDD, into which these directives were transposed (in particular Czech Act No. 268/2014 Coll., on medical devices, as amended).
The reprocessing and further use of single-use medical devices
MDR also brings innovations in reprocessing of single-use medical devices. The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in MDR.
Anyone who performs reprocessing of single-use devices for this device to be suitable for further use within the EU, it is considered to be a manufacturer of reprocessing device and takes over the obligations imposed on manufacturers. These responsibilities include the obligation to state yourself as a manufacturer on label of reprocessing medical device and also the number of reprocessing cycles, which can be performed. The original equipment manufacturer´s identification is no longer indicated on the label but remains in the instructions for use of the restored device.
The new legislation of MDR in connection with medical devices brings changes focusing in particular on a high level of protection of the health of patients and users of medical devices, which is reflected in the introduction of new institutes, for example, Unique Device Identification system or introducing new requirements for reprocessing single-use medical devices lay on reprocessing of single-use devices or supplementary obligation to publish additional information about the medical device provided by the manufacturer to the user.
Certainly, the new legislation will require considerable demands on manufacturers and distributors of medical devices in the EU, but they still have a year to prepare before MDR becomes directly applicable. In connection with the applicability of MDR, we can expect an amendment to the Czech Medical Devices Act and implementing legislation, which we will monitor for you.
If you have any questions about medical devices in the light of new and existing legislation, please contact us.
Mgr. Bc. Štěpánka Vajdová, junior lawyer – firstname.lastname@example.org
Mgr. Jakub Málek, partner – email@example.com
27. 05. 2019