The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards. Here is what you need to know about the US FDA’s inspections and enforcement actions and how to prepare for them.
The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA). They must understand and comply with the US FDA’s regulations to successfully launch their products in the US.
Brazil, the largest economy in Latin America (LATAM), is also the most promising medical device market in the region. The medical device market in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, which came up with a new resolution titled RDC 751, effective from March 01, 2023.
The Swiss Mutual Recognition Agreement (MRA) for medical devices between the EU and Switzerland has lapsed on May 26, 2021, and the negotiations between Switzerland and the EU have concluded without any concurrence on Institutional Agreement (InstA). Under the lapsed MRA between the EU and Switzerland, the requirements for medical devices defined under the Swiss Medical Device Ordinance (MedDO) were compliant with the EU MDD and EU AIMDD.
The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.
It is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19. In simple terms, the EU MDR aims to provide device clinical safety and effectiveness by establishing a robust, transparent and sustainable Regulatory framework that is recognized internationally and improves fair market access for manufacturers.
The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices. In addition, this position paper defines the data elements for BASIC UDI and UDI-DI groupings for spectacle lenses and ready readers.
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.
Therefore, the key is to carefully prepare the medical devices labels aligning with the EU MDR labeling requirements, such as:
