SAFEGUARDS | Electrical & Electronics NO. 130/17
On April 5, 2017 the European Parliament approved the new Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. They entered into force on May 26.
On April 5, 2017 the European Parliament decided to approve the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The Council of European Union had already approved the regulations in early March. The final text was published in the Official Journal of the European Union on May 5 and entered into force on May 26 2017. This means that the new regulations are part of European legislation.
The final text has changed considerably from the draft of June 2016. There are a lot elements from the Medical Devices Directive (MDD) 93/42/EEC (60 pages), but the MDR extends to 175 pages and is expanded both in depth of details and in coverage.
The MDR will be applied in full from three years after the date of entry into force, in other words on May 26, 2020, and the IVDR will be applied after five years. This will also mean that the directives will become void after application of the regulations. Designation of current notified bodies according to the directives will also become void on the date of application. However, the regulations state that the notified bodies shall continue to be responsible for surveillance of certificates that they have issued. How this apparent mismatch will be solved is still an open question.
Key Impacts of MDR
- Certificates issued prior to the date of entry into force shall remain valid until the validity date stated on the certificate, typically five years from issue. The exception to this is certificates issued in accordance to Annex IV to Directive 93/42/EEC, which shall become void two years after the date of application of the MDR at the latest
- Notified bodies can issue EC certificates according to the MDD until the date of application of the Regulation. The certificates can be issued to be valid for five years, but they shall become void four years after the date of application of the MDR at the latest
On Applying the Regulation:
- The definition and scope of medical devices has been expanded in the Regulation. The definition will include products that are used for prediction or prognosis of a disease. It will also include products that are used for cleaning, disinfection or sterilization of devices
- A new category of devices are products that do not have a medical use, but that will be controlled for safety reasons. These will include contact lenses used for cosmetic purposes, cosmetic implants, injections for dermal or mucosal fillings, equipment intended to be used for removal of adipose tissue (liposuction etc.), high intensity electromagnetic radiation equipment used for treatment of skin and equipment intended for transcranial electromagnetic stimulation of brain. The Commission will able to expand this list later
New Requirements for Manufacturers and Other Economic Operators:
- In addition to manufacturers and authorized representatives, importers and distributers have been added to economic operators. Each operator will have specific added responsibilities. Manufacturers will need to prepare for this with suitable agreements
Every manufacturer shall apply a quality management system. As today, only manufacturers for higher risk class devices (Im, Is, IIa, IIb, III) will need to have a notified body to assess functionality of the QMS
Every manufacturer shall have available within their organization at least one person responsible for regulatory compliance. The Regulation defines the minimum qualifications for this person. Small companies will not need to employ the person responsible for regulatory compliance but shall have such person permanently and continuously at their disposal
Traceability of medical devices will be carried out by applying a Unique Device Identifier (UDI). The system is supposed to be compatible with requirements of FDA, so there will be only one UDI on the device. This comes together with expansion of the current Eudamed database, that is currently being applied by authorities only. In the future, the public will also be able to access Eudamed not only to check the certification status of each device but also for other safety information
“Essential performance” has been replaced by “General safety and performance requirements” (Annex I)
Requirements for technical documentation of the product (Annex II) have been expanded and clarified
Required labeling information has been made more detailed. Specific attention has been paid to misleading claims (off-label use etc.) that are explicitly prohibited
The current 18 classification rules have been expanded to 22 rules. Apart from SW classification, there are no significant changes to rules
- Guidance to implementation and interpretation of Directives has been given as MEDDEV publications. In the Regulations this guidance has been included in the text, for example requirements for generation of Clinical Evaluation Report. This means that the requirements will be compulsory instead of informative
As previously mentioned, the new MDR consists of 175 pages of Articles and Annexes. This means there is a lot of detail and this article covers just some of the key points. We will be arranging training for the contents and interpretation of the Regulation and will be pleased to give further information.
SGS Fimko Ltd is going to provide notified body services after Regulations come in effect. The process for designation can be started six months after the Regulation’s entry into force.
At SGS, our services enable you to deliver well-designed, functional, durable and safe products to you customers. We have the electrical and electronic industry regulatory and technical expertise to check your products’ compliance against relevant standards and/or your own specifications. Please do not hesitate to contact us for further information or visit our website.
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