FAQ

To accelerate the development and approval process of medical devices, manufacturers must stay abreast of changing requirements and implement foolproof compliance strategies. Manufacturers who implement a strong regulatory strategy early in the development process will notice significant gains once they submit their product in the various medical markets. A good regulatory strategy will allow you to properly assess the risk of your device, understand what is required of you based upon the risk assessment, and assemble the proper documentation and evidence needed to prove the device is safe and effective in its intended use.

GMREs unique program supports major and emerging medical markets’ certification and compliance efforts, including the FDA, EU and ISO, and allows medical device manufacturers to align their product development cycle with the regulatory certification cycle, making their overall time-to-market process faster and more efficient.

Significant adjustments in the language used in the new regulation will require manufacturers to review their technical documentation and perform a global impact assessment in order to implement the necessary changes to remain compliant. Most manufacturers will have to revise the clinical data, technical documentation, and labeling of their medical devices. The clinical data generated and provided will have to be more detailed and in-depth than before in order to demonstrate safety and performance.

Moreover, the General Safety and Performance Requirements (Annex I) determine new conditions that will need to be addressed for most products previously CE marked under the MDD 93/42/EEC. Existing devices will have to be recertified in accordance with the new rules.

The definition of a medical device is extended to encompass cosmetic and non-medical devices not previously regulated, such as products for cleaning, disinfection or sterilization of the devices.

Unique Device Identification (UDI) will be implemented to help track medical devices throughout the supply chain and will be required on all labels.

Companies undergoing such transitions will need to revisit core processes including quality assurance, risk management, and post-market expectations.

For a GMRE MDR gap analysis and assessment for your medical devices, contact us today.

When deciding on a consulting company for your Regulatory & QA Affairs, GMRE suggests making sure the company can meet the following criteria:

1. Consultants should have a long-standing presence in the medical industry field and extensive experience in providing RA/QA services.
2. The company should offer experience in the various global medical markets and possess a thorough understanding of their respective rules and requirements for the medical device to be certified in the quickest and most efficient way.
3. The company should be equally adept in the manufacturing and design process and have first-hand experience in the technological R&D procedures involved.