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- when the medical device has the CE marking: by notification,
- when the medical device has not CE marking: by national conformity assessment and registration.
The approval process takes 45 days for Class I devices, and 90 days for all other classes of devices.
Licenses issued in Moldova expire after five years.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The new MDR significantly impacts the steps to not only obtaining a CE marking, but maintaining it as well.
The CE marking on a medical device allows it to be freely traded in the EEA, and legislators are anxious to ensure the device meets all regions’ standards for patient safety and environmental protection. As a result, the process of receiving the CE marking is far more rigorous than under the Medical Device Directive of years past.
Here are some of the major changes in CE marking for medical devices:
Classification. Rather than depending on predicate devices or a decision tree, device classification under MDR is determined by intended use.
Person Responsible for Compliance. Article 15 of MDR requires the appointment of a Person Responsible for Compliance (PRRC), a designated employee with regulatory experience as defined in the regulation, as well as experience with quality management systems or regulatory affairs.
Authorized Representative. Any manufacturers not established in the EU must appoint an Authorized Representative before obtaining a CE marking. Authorized Representatives must be operating in the EU, and will remain the primary liaison between the manufacturers, notified bodies, and national competent authorities. The contact information of the Authorized Representative must also be displayed on all packaging and labeling.
Notified Body Review. This process will have far more scrutiny, with three rounds of questions and require a significant investment in resources and time. If your device is approved, your CE marking certificate will be good for up to five years.
Maintaining CE marking. Though the CE marking is valid for five years, manufacturers are still required to undergo random audits from notified bodies, keep ongoing technical documentation, and perform extensive post-market surveillance.
Medical devices are regulated by the Medicines and Medical Devices Agency of the Republic of Moldova. CLASSIFICATION SYSTEM: Devices are classified according to the risk-based EU model of Classes I, IIa, IIb, III, and IV.
An authorized representative is required.
TÜV SÜD has the expertise and laboratory infrastructure to support manufacturers in obtaining the necessary approvals and compliance in accordance to the Moldova’s standards and requirements. TÜV SÜD test reports are widely accepted and recognised by authorities internationally.
The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
The EU Medical Device Regulation (EU MDR) defines the term “medical device” as an “instrument, apparatus, appliance, software, implant, reagent, material, or other article” that is used for any of the following:
Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention
Investigation, replacement, or modification of an anatomical, physiological, or pathological process
Providing data via in-vitro examination of samples derived from a human body