The European Union’s (EU) new Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) entered into force on May 26, 2017. The MDR will be applied in full, from May 26, 2020, and the IVDR will be applied in full, from May 26, 2022.
Stakeholders should be aware that the final texts for these pieces of legislation differ considerably from the drafts issued in June 2016. They are essentially greatly expanded, both in depth of detail and in coverage, versions built upon elements of Medical Devices Directive (MDD) 93/42/EEC. Current directives will become void following the application of these regulations.
The key transitional provisions are:
- 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
Key impacts for stakeholders applying the new regulations:
- 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 EC will be able to expand this list as required
Key changes for manufacturers and other economic operators:
- Importers and distributers have been added to the list of economic operators, alongside manufacturers and authorized representatives. Each operator will have specific added responsibilities. Manufacturers will need to prepare for this with suitable agreements
- Every manufacturer must apply a quality management system. Currently, only manufacturers for higher risk class devices (Im, Is, IIa, IIb, III) need to have a notified body to assess functionality of the QMS
- Manufacturers must have at least one responsible person for regulatory compliance. Minimum qualifications are defined in the regulations, along with stipulations that small businesses do not need to employ such a person but such a person must be permanently and continuously at their disposal
- Medical device must carry a Unique Device Identifier (UDI) to aid traceability. The system should be compatible with FDA requirements to allow only one UDI per device. This comes alongside the expansion of the current Eudamed database, which now be accessible by the public
- “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 on the implementation and interpretation of Directives has previously been given as MEDDEV publications. This is now included in the regulations, for example requirements for generation of Clinical Evaluation Report. This means that the requirements will be compulsory instead of informative
The entering into force of these pieces of legislation follows their approval by the Council of the European Union in early March 2017, their approval by the European Parliament on April 5, 2017, and their publishing in the Official Journal of the European Union on May 5, 2017.
Manufacturers and economic operators need to aware that the new MDR is 175 pages long, in contrast to the 60 pages of the previous directive. This article covers some key points, but stakeholders should familiarize themselves with the full document or work with regulatory experts in order to ensure continued compliance.
SGS Medical Devices Services
SGS’s medical device testing, certification, audit and training services help companies navigate the complexities of international medical device regulations to bring their products to market quickly whilst ensuring compliance with the required regulations and standards. Learn more about SGS’s Medical Devices Services.
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