EU MDR requirements have been a frequent topic of discussion for medical device manufacturers over the last few years with many wondering who will comply and who will withdrawal from the market. While other manufacturers elected to withdrawal, G&H has invested the time and money to support the application of the EU MDR regulatory framework. Read through the below FAQ for more information.

Below, we answer the following questions:

  • How has the EU MDR impacted G&H’s ability to manufacture and distribute products in the EU?

  • How important is compliance with the new EU MDR to G&H?

  • How does G&H intend to support the application of the EU MDR regulatory framework?

  • How confident is G&H in your ability to satisfy the rigorous requirements contained within the EU MDR?

  • How has G&H satisfied the requirement of identifying at least one “qualified person” within the company who is responsible for all aspects of compliance with the requirements of the new MDR?

  • Glossary

 

How has the EU MDR impacted G&H’s ability to manufacture and distribute products in the EU?

The application of the EU MDR standards in May of 2021 should have come as no surprise to medical device manufacturers. Since its introduction in 2017, G&H has been preparing to meet the new bar for medical device safety and efficacy.

In anticipation of the increased requirements, we’ve hired numerous employees and expert consultants to help us navigate the changes between MDD and the new EU MDR and demonstrate compliance.

We are counting on this advanced planning to position us ahead of manufacturing peers in the orthodontic industry that have not been as aggressive in conforming with the new regulation. We’ve monitored EU MDR updates to timelines and requirements which has helped us deal with the complexities of this initiative and set us up for a successful transition to the new requirements.

 

How important is compliance with the new EU MDR to G&H?

While other manufacturers have elected to withdrawal products from the market, either due to an inability to conform with the new requirements or general lack of interest, we remain committed to making available the orthodontic products and devices we’ve provided globally for more than 40 years.

With our long history of developing brackets, wires, elastomeric, aligners, bands, and attachments, we are committed to continuing to provide high-quality, reliable products for the EU market and world at large. We are in the process of submitting 22,000 products for CE marking under the MDR signifying our products meet the applicable health, safety and environmental requirements outlined in the EU MDR.

We believe that these new regulations will ultimately improve greater patient safety and look forward to continuing to support the initiatives of the EU MDR governing body.

 

How does G&H intend to support the application of the EU MDR regulatory framework?

According to an August 2021 MedTech survey of medical device professionals, approximately 75% of medical devices on the market have yet to comply with the European Union Medical Device Regulation. At G&H Orthodontics, our goal has been to lead the way in moving to meet MDR compliance standards. We began the process early, in 2019, and have invested more than $1 million dollars and over 26,000 hours to ensure our products meet MDR requirements so that we can continue to provide uninterrupted service to our customers.  

The change from MDD to MDR in the European Union is significant but follows an emerging trend of more rigorous safety and efficacy requirements for medical devices. As an example of one measure, we’ve taken to satisfy the EU MDR requirement to increase product traceability, G&H has adopted the use of unique device identification (UDI) mechanisms.

 

How confident is G&H in its ability to satisfy the rigorous requirements contained within the EU MDR?

The MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. Changes in the regulation include expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies. Based upon our investment in time, people, and monetary resources we are confident that we will successfully conform with the EU MDR legal and regulatory requirements that allow our products to be marketed in the European Union.

 

How has G&H satisfied the requirement of identifying at least one “qualified person” within the company who is responsible for all aspects of compliance with the requirements of the new MDR?

In addition to appointing a strategic Director of Regulatory Affairs and Quality Assurance, we have a dedicated G&H team of professionals focused on executing our transition plan. In addition, we feel it’s important that all employees are informed of the impending regulatory changes and are trained and qualified to effectively implement them.

 

Glossary

What is a medical device?

A medical device means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more defined specific medical purposes.

 

Who is a manufacturer?

The regulation defines a manufacturer as a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark.

 

The EU’s Medical Device Regulation (EU MDR)

The EU MDR is a regulatory framework developed to replace existing Medical Device Directives (MDD) for medical devices (93/42/EEC) and active implantable medical devices (90/385/EEC).

 

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