Updates on the EUMDR

In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021.

The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in this push-back, keep the ball rolling on meeting new MDR compliance. Those scrambling to review their products’ compliance may be able to exhale, but the race to completion is still on.

In 2017, EU came out with the new MDR, that would go into effect in 2020. Since then, medical device manufacturers have been tasked with determining which of their products need to be re-registered with participating Notified Bodies, in order to meet the new regulations for export in the EU. However, this posed a new problem for RA professionals.

The once lengthy list of Notified Bodies has now dwindled to only a handful. This poses a great problem for many manufacturers as Notified Bodies become more and more overwhelmed with products to register.

Arthrex: Manufacturing Face Shields for Healthcare Workers Amidst COVID-19 Crisis

The panic at the spread of the dangerous virus caused a spike in hand sanitizer, toilet paper, and unfortunately, extremely crucial face masks. With this horrifying scarcity looming over our healthcare providers, companies and communities alike are stepping up and coming together to do what they can to protect our frontline workers.

Arthrex, a massive Southwest Floridan company, mainly specializes in manufacturing orthopedic devices for surgeons, with the mantra “Helping Surgeons Treat Their Patients Better.” However, the outcry from our hospital heroes left Arthrex hoping to help. On April 14th, an FL news station reported “Arthrex has made 300 face shields and 25 protective hoods” and they’re en route to producing “up to 500 face shields a day.”

This whole process has been truly inspiring to see both the community at Arthrex and the community at large rallying together against the battle against COVID 19….It’s not just the first responders and the nurse. We’re all in this as one”

Dr. Christopher Adams

Click here to read the full article about Arthrex’ involvement in protecting our hospital workers in this pandemic.

Washington Consular Services is immensely proud of Arthrex’ dedication in getting in front of the spread of the COVID-19 virus, and by being their Apostille and Legalization partner.

Abbott Launches a Five Minute Test to Detect COVID-19

On March 27th, Abbott announced that the FDA had approved and declared their COVID-19 detection test the fastest on the market. At the crippling rate this is spreading, a quick test is more critical now than ever.

The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines

  • Test to run on Abbott’s point-of-care ID NOW platform
  • a portable instrument that can be deployed where testing is needed most- ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings
  • Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day
  • This is the company’s second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

-Abbott

Read the full press release from Abbott here.

Washington Consular Services is immensely proud of Abbott’s dedication in getting in front of the spread of the COVID-19 virus, and by being their Apostille and Legalization partner.

Times Article: “Becton Dickinson Seeks Emergency FDA Approval for a Two-Hour Coronavirus Test”

On March 17th, Times magazine released an article informing the public that Becton Dickinson (BD) is seeking emergency FDA approval for a two-hour coronavirus test. If approved, this would save hospitals up to two weeks of time in diagnosing a patient. Not only is this positive news, but it may prevent an increasingly growing influx of patients in hospitals worldwide.

The article states that this method has already been utilized overseas. BD’s hope is that FDA’s emergency approval will allow its implementation in the United States.

“According to [BD] CEO Tom Polen, the test has already been used in China, including at the pandemic’s epicenter in Wuhan, and in Europe. The company has partnered with Alabama-based biotech company BioGX and asked the FDA for approval to use its test in the U.S. under the agency’s Emergency Use Authorization, which allows expedited review of new tests under emergency circumstances such as a pandemic.”

Alice Park for Times Magazine

BD states they’re currently working on developing another test that cuts the results delivery time in half. The test would be sixty minutes long, handheld, and available to retail clinics nationwide.

Read the full article here: https://time.com/5804222/two-hour-coronavirus-test/

Washington Consular Services is immensely proud of BD’s perseverance in preventing the spread of the COVID-19 virus, and by being their Apostille and Legalization partner.

Europe’s New Medical Devices Regulations 2017/745(MDR) deadline is finally here!

European Union Medical Device Regulation 2017/745 deadline approaches on May 26, 2020. Medical device companies must comply with the new regulations to maintain market access and mitigate risk.

Medical devices and implantable objects have not faced the high level of regulation the public might expect. This is beginning to change. The European Commission has deemed regulations passed in the 1990s insufficient, and with the desire to strengthen legislation for public safety, the new European Union (EU) Medical Device Regulation (MDR) 2017/745 was born. The EU MDR, which takes into consideration technological and scientific progress made in the last 20 years, will increase the amount of data required to put medical devices on the market. This includes items that serve cosmetic purposes, which were previously out of scope.

What is EU MDR?

The EU MDR was first proposed in September 2012, and accompanied by a separate, complementary regulation targeting in-vitro devices. These regulations were developed to increase the safety of medical devices for the general public, as well as improve traceability and legal certainty. Regulators devised the EU MDR because the existing regulation, the EU Medical Device Directive (MDD), was outdated and provided insufficient standards for maintaining safe and properly-functioning medical devices. The regulation entered into force on May 25, 2017, with a transition period for manufacturers that will continue until May 26, 2020.

Currently, there are 500,000 existing, registered medical devices. The majority — 314,000 — will need to be re-certified under the EU MDR in order to maintain market access.

EU MDR NEW RULES HIGHLIGHTS FOR MEDICAL DEVICE MANUFACTURER’S
  • Manufacturers will be able to register a device once at the EU level, instead of having to go through multiple registration procedures.
  • Clinical trials taking place in more than one EU member state will be subject to a single coordinated assessment instead of multiple national assessments.
  • The European database will expand to contain extensive information on medical devices, with most made publicly available.
  • Implant cards will include more information for patients
  • There will be a financial plan for patient compensation in cases where people have been harmed by medical devices.
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