Cogent Corner

Second Quarter (Q2) · June 1, 2019

The second quarter of 2019 looked strangely similar to the first. Brexit ruled the headlines, and the U.S. Food and Drug Administration continued making significant news in the lead up to and immediately following the departure of now-former Commissioner Scott Gottleib.

While the United Kingdom has pushed its deadline for leaving the European Union back multiple times and yet to finalize any plans towards its new October goal, the European Commission found that “the majority of medical products concerned by the UK withdrawal should be compliant with EU legislation on the withdrawal date.”

The European Medicines Agency has also reported good progress in preparing for the impending departure as it takes on additional priorities and reinstates previously halted tasks to its work for 2019, including projects aimed at increasing the efficiency of the agency’s operations, such as with IT systems supporting medicine evaluations and the digitalization of administrative processes.

During late May and in order to aid decision-making among competent authorities, notified bodies and economical operators, including device manufacturers and authorized representatives, the European Commission issued guidelines on data exchange solutions around compliance with MDR’s future version of Eudamed. The EC has also recently requested the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for draft revisions to existing standards and create new standards in support of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).

And via a new working group, medical device regulators have launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the MDSAP for additional countries to participate. A new category for interested countries to participate in MDSAP is also under development.

In the U.S., former FDA Commissioner Gottleib addressed all agency staff and the general public for a final time before returning to the venture capital firm, New Enterprise Associates, as a full-time investing partner.

Here are the other key updates from the last three months:

UNITED STATES

1. He’s already had the pleasure of debuting the agency newly redesigned website, but more than two months after being welcomed to the FDA’s helm, acting commissioner Dr. Ned Sharpless is still awaiting questioning and confirmation by the U.S. Senate.

And another task Gottleib completed before passing the FDA baton to Sharpless was unveiling a proposed framework to allow ongoing artificial intelligence algorithm changes based on real-world learning. Modifications to traditional software as a medical device (SaMD) that could have a significant impact on the safety or effectiveness of a device would still require a submission to FDA.

1. One of the two sterilization plants to dominate the medical industry news cycle earlier this year due to an unexpected closure, is now facing new hurdles to its reopening -- congressional action due to concerns over its emissions standards.

1. As new medical devices are improve patients' quality of life and help them live longer, a new report has found that hospitals are caught between the jump in first-time premarket device approval, inadequate reimbursement and premium prices for the procedures that are often significantly more expensive than current therapies.

1. The FDA issued new guidance in April around non-clinical bench performance testing for medical devices that manufacturers should include in premarket submissions, including test report summaries, test protocols and complete test reports. These recommendations were closely preceded by draft guidelines regarding premarket submissions for products containing nitinol, an alloy of nickel and titanium commonly used to manufacture medical devices, and the FDA’s approval of the first medical device to be indicated for attention deficit hyperactivity disorder (ADHD) treatment.

1. An April 384-page budget justification from the FDA raised significant concerns over how the agency would approve risky medical devices for life-threatening conditions, and empower regulators with a two-step approval process allowing companies to generate safety and effectiveness evidence after a device is already on the market. This developments followed the FDA’s announcement to reclassify eight types of medical device accessories to class I, including gastroenterology-urology accessories; biliary stent, drain and dilator accessories; and suprapubic catheter accessories.

1. In Massachusetts, exports of medical devices increased 7.7% last year, bringing the total value of shipments by the state's industry to more than $6.1 billion, but the new data also revealed a roughly 17% decline in 510(k) clearances originating in the state.

1. After the FDA tried to assure the public in early May that it was not taking action to limit the use of old 510(k) predicates anytime soon, a chorus of medical device manufacturers urged the agency to not limit use of 510(k) predicates on the basis of the age of devices used as a reference product.

1. A few weeks ago the U.S. House Appropriations Committee voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts.

CANADA

1. Between now and August 26, the public can submit comments to Health Canada on “proposed rule changes intended to improve the safety and effectiveness of life-saving medical devices such as insulin pumps and pacemakers”. This news comes a month after country regulators announced plans to revise medical devices fees to 50% to 100% of costs over four to seven years, and also issued new guidance for manufacturers of higher-risk 3D-printed medical devices.

EUROPE

1. Earlier this month, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations to address the ongoing lack of notified bodies designated under the European Union’s medical device regulation and confusion regarding the regulation’s grace period.

1. The European Union’s Medical Devices Coordination Group issued new guidelines in May around entry timelines for the Eudamed medical device database, and the development of Unique Device Identification (UDI) data for "legacy devices." The new rules address the Eudamed legislation, including UDI assignments and agency designations.

1. Starting this month, the Spanish notified body is no longer accepting new medical device applications from new clients for CE marking, and will also cease to process new certificate applications from existing clients by the close of July.

1. With the European Union’s new medical device regulation coming into effect in less than a year, seven medical device industry groups — including  AESGP, Ehima, Eurom VI and Euromcontact — recently called for an acceleration in the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.”

1. Following a recent investigative news report about the underuse of medical device tracking and a designated surveillance system, Italy’s health minister has announced new registries for breast implants and orthopedic devices.

1. As the European Commission (EC) designates new standards organizations as the issuing entities for unique device identifiers, the industry and the EC question whether the Europe Union’s new stricter regulations will have dire consequences when they go into effect next year.

AFRICA

1. Egypt’s new fast-track medical device registration pathway — a feature made available in early 2018 — is showing key initial results and success. The Egyptian Central Administration of Pharmaceutical Affairs’ review times have been reduced to three months for sterile and non-sterile disposable devices — a huge reduction from previous market access time frames of a year or more.
   

AUSTRALIA 

1. Australia’s first quarter progress included work around reclassifying a number of medical device types and categories, including SaMDs, spinal implants, and organ storage solutions. These changes will be complemented by the Therapeutic Goods Administration’s newly released three-part medical action plan — a strategic effort boost oversight and “increase transparency with stakeholder consultations and forthcoming guidance materials”.

BRAZIL

1. Long before our spring update on ANVISA’s plans for a new Class I process, the Brazil medical device market regulator was already working towards revised requirements around custom-made tools, such as 3D-printed medical products. Following a series of discussions in early June, changes to this regulatory structure will also include adaptable medical devices and patient-specific medical devices.

INDIA

1. In early 2019, Cogent Corner readers received news of India’s plans to reclassify certain medical devices and equipment as drugs. Further developments around this work were released in May 2019 by the Indian Central Drugs Standard Control Organization (CDSCO) — noting new Class B and Class C distinctions for items like blood pressure monitors, defibrillators, CT scanners, glucometers, and nebulizers.\

EAST ASIA

1. Mid May saw the effects of U.S. and China’s trade war on the medical device industry. Products like imaging equipment, diagnostic reagents, surgical gloves and contact lenses are now subject to a new 10% to 25% tariff under the United States Trade Representative — with China also levying a similar tax in response on various items, including X-ray examinations and lamps used in medical settings.

1. China also experienced a “38% decline in medical device registrations” approved by its National Medical Products Administration in 2018 compared to 2017. While no concrete reason has been identified for this decrease in activity, the country’s ongoing regulatory changes — including updates to its electronic registration system and technical review guidelines — are said to be contributing factors.

1. And juxtaposed in the same region, but nearly 2,000 miles away, Japan’s regulators have recently increased their medical device registration fees, while the Japanese Ministry of Health, Labour and Welfare also extends participation in the country’s Medical Device Single Audit Program through early 2020.

MEXICO

1. As quickly as fears started to mount around the financial effects device manufacturers expected from new U.S.-Mexico tariffs, they were quashed a week later upon the announcement of a new trade deal.

MIDDLE EAST

1. And while this summer is seen by some as welcomed reprieve from Brexit’s large and looming impact, regulators in Saudi Arabia are among many with the new October deadline still front and center in their minds. In preparation, the Saudi Food and Drug Authority (SFDA) has prepared adjustments to its medical device and IVD registration requirements and has also drafted UDI guidance as well as a Brexit contingency plan.

First Quarter (Q1) · April 1, 2019

First quarter 2019 brought a lot of developments and unanswered questions for the medical device industry, particularly across North America.. From the recent shutdown of its federal government and closure of a major device sterilization plant to the FDA Commissioner announcing his April departure, all eyes were on the U.S. market’s changing regulatory landscape.

The early part of this year also created an unifying medical opportunity of sorts for Australia, Brazili, Canadian, Japan and the United States. Respective country members of International Medical Device Regulators Forum (IMDRF) have come together around the Medical Device Single Audit Program (MDSAP) -- an audit program designed to coalesce and standardized global regulations on medical devices -- so the five markets can meet all of their requirements with a single audit.

But, let’s not forget the European Union.

Brexit is still a very real and critical issue for device manufacturers and policymakers. The March 29 deadline has been extended to April 12. However, the major players are still unsure of what will come of the UK’s intent to recede from the EU. Most understand easily how beneficial the current system of interconnected medical device oversight and approval requirements is for EU members and partners. Figuring out what comes next -- post Brexit -- is the hard part.

Here are the other key updates from the last three months:

UNITED STATES

1. A few weeks after declaring 2018 as a breakout year for novel medical devices, and reassuring device manufacturers the federal government shutdown would have no effect on the agency’s review process, Commissioner Scott Gottlieb revealed he would leave his post at the U.S. Food and Drug Administration in April 2019.

1. Like any leader of a federal agency, Gottlieb’s two years at the helm of the FDA came with its share of praise and criticism. Memorable moments from his tenure include a focus on transparency, using social media, and increasing regulation of certain products compared to others. The Brookings Institution recently hosted Gottlieb for a chat about his time in public service, thoughts on government policy, and plans for the future.

1. While we await confirmation of the next FDA Commissioner and digest the agency’s new regulatory priorities as part of the 2020 budget process, the industry is raising concerns about the FDA’s new guidance around cybersecurity and braces for the closure of a second sterilization plant -- even as the FDA steps up its efforts to prevent a possible medical device shortage. 

1. In other U.S. regulatory news, the FDA is looking into stricter oversight of the materials used medical devices, recently started a new pilot to evaluate issues with 510(k) submissions, and following a mid-February introduction in the U.S. House of Representatives, a bill to repeal taxes on medical devices has also found supporters in the U.S. Senate.

CANADA

1. In addition to launching an online tool to help the public better understand how medical devices are regulated, Health Canada recently released two public databases of clinical information about the safety and effectiveness of drugs and devices.

EUROPE

1. Since the start of 2019, we’ve provided Cogent Corner readers with the latest and greatest FAQ documents and guidelines for a deal or no deal Brexit outcome. As the United Kingdom faces a new April 12 deadline and hope for a positive development proceeds, manufacturers are still working to meet the clinical data needs of the new European Medical Device Requirements. We shared the EU’s first Q&A on these regulatory changes in March 1st edition of Cogent Corner. A updated round guidance was also released by MHRA in late March.

1. A few days before Brexit’s deadline was given a reprieve, Dutch officials wasted no time issuing their own medical device directive around a no-deal conclusion.

1. In an effort to streamline the categorization and review process, officials regulating the “implementation of the European Database for Medical Devices have decided to adapt medical device codes used by the Italian Ministry of Health for use as nomenclature for the database”. You might recall Cogent Corner’s previous mention of this issue within the World Health Organization. Back in early February, the WHO revealed its progress towards a global nomenclature around medical devices.

1. France is aso weighing in on Europe’s current “pre-Brexit” regulation of medical devices. Calling the system “massively dysfunctional,” French authorities are “advocating for 36 separate reforms,” including increased vetting and oversight.

AUSTRALIA 

1. Australia’s move towards a more thorough reclassification of SaMDs, spinal implants, and and personalized medical devices is a development we shared a little over a month ago. The country is continuing its efforts to align with the EU’s MDR by announcing a classification change for five specific medical device types -- including human cell, tissue and organ storage solutions, and medicines administered via inhalation tools.

BRAZIL

1. In case you missed this news from our March 1st update, experts say ANVISA is rolling out new Class I device registration and approval requirements that could go into effect as early as May 2019.

INDIA

1. The February 2019 editions of Cogent Corner gave readers a peek at India’s forthcoming reclassification of implants and imaging equipment and projected medical technology boon from the country’s new regulatory environment.

EAST ASIA

1. China announced plans back in February to begin implementing more rules around overseas inspections.

1. For those of you needing a primer or refresh on how medical devices are inspected and funded by APAC’s healthcare industry, read through these recent overviews from subject matter experts in Japan and China.

MEXICO

And lastly, a similar rundown on the regulation and oversight of Mexico’s medical industry was published in late March.

March 1, 2019

Brexit. Still a topic very much on the minds of every business and regulatory entity. We’re less than a month from the deadline, and tons of questions still loom. To help ease fears, lawmakers are stepping up with some preemptive guidance if no deal is reached. 

1. • MHRA’s new “no Brexit deal” guidelines for medical devices covers everything from registration process and fees to new classification rules and registration fees.

1. • And the Brexit related directives don’t end there. The British Standards Institution wants device manufacturers to immediately migrate existing CE certificates from BSI UK to its Netherlands (NL) entity “as a matter of urgency.”

1. • If you’re seeking a deeper dive on the latest and greatest with Brexit and how it will impact your operations, see this detailed Q&A.

Here is a Cogent Corner rundown of other important news you may have missed: 

1. • While the FDA’s chief recently pledged device manufacturers will not be impacted by the recent government shutdown, the closing of an Illinois plant could have the damaging effect we all feared.

1. • Experts say Brazil’s regulatory body (ANVISA) new Class I device registration and approval requirements could go into effect as early as May 2019.

1. • May 2020 is quite a while away, but to help device manufacturers acclimate to regulatory changes going into effect for drugs that use pre-filled syringes and pens, the European Medicines Agency released a new device Q&A.
5. • Null and void. Following the three-year transition period, that’s the new status of all ISO 13485:2003 certificates as of Friday. ISO 13485:2016 Compliance places greater emphasis on QMS, supplier management & device lifecycle among other things.

February 15, 2019

Is it time to label reclassification as a buzzword? If any of the top news we have for you this week is any indication, 2019 might be the year to make that happen. Between the influence of the European Union, the evolution of medical software, and the impending Brexit deadline, industry players and regulators are doing more to ensure the devices we depend on are properly monitored and implemented.

1. • In a move towards a more thorough reclassification of SaMDs and personalized medical devices, Australia’s Therapeutic Goods Administration has released new regulatory guidance.

1. • This development comes days after Australia’s regulatory body also announced plans to reclassify spinal implants to better align with the European Union.

1. • Starting next year, implants and imaging equipment in India will be classified as drugs -- and potentially receive more regulatory oversight.

 

Here is a Cogent Corner rundown of other important news you may have missed: 

1. • A group of U.S. lawmakers are working to repeal the medical device tax in an effort to free up industry dollars for research and other needs. See the official bipartisan appeal here.

1. • Even with so many unanswered regulatory questions looming ahead of Brexit’s March 29th date, some members of the United Kingdom’s parliament are focused on reforming what they see as an already broken medical device market.

1. • A device created to treat brain tumors is slated to receive expedited attention thanks to a unique FDA designation.

February 8, 2019

Another shutdown of the U.S government is still a possibility this month, but life in the medical device industry will have to carry on. Here are the major highlights over the last week to keep your mind focused:

1. • Earlier today, the U.S. FDA released guidelines on the exemption of certain medical devices from 510(k) requirements, in an effort to decrease regulatory burdens and reduce the financial costs that currently plague the industry.

1. • The World Health Organization revealed its progress towards a global nomenclature around medical devices. What does this mean exactly? Simply put, 90 countries currently having an official regulatory system for medical devices and the WHO needs a more streamlined approach to identifying the plethora of devices based on their various classifications across borders. The agency notes this new system will help create more universal health coverage and better facilitation during emergency interventions.

1. • What two factors are expected to create a spike in the need for neurological devices? Minimally invasive surgeries and an ageing population.

And here is a Cogent Corner rundown of other important news you may have missed: 

1. • The need for medical devices designed specifically for pediatric patients is getting renewed attention from the academic and research communities.

1. • A new local approval requirement has been issued for all medical devices sold within Vietnam, and its border neighbor, China, is implementing more rules around overseas inspections.

1. • More players in the startup community are stepping up to create cybersecurity tools for medical devices.

1. • Ireland is asking the medical community to prepare itself and reach out regarding potential Brexit disruptions.

1. • A newly streamlined regulatory environment is projected to create a huge boon for India’s medical technology industry.

1. • Mark your calendars for a few dates in March. The FDA’s medical device advisory unit is scheduled to take up Human Papillomavirus (HPV) screening devices along with a host of other new neurological and surgical tools. 

February 1, 2019

A lot happened during the first month of 2019. The major highlights:

1. •  After a five-week shutdown, the U.S. Federal Government reopened (at least thru Feb. 15).

1. • Negotiations around Brexit are still in flux even as we close in its ominous deadline (make sure your calendars are marked for March 29).

1. •  The FDA released data this week touting 2018 as a breakout year for novel medical devices.

 

And here is a Cogent Corner rundown of other important news from the last month: 

1. • Europe designated the first UK notified body to the new MDR (EU 2017/745), marking a huge milestone for the Notified Bodies Operations Group projected timeline. Click here to learn more about The British Standard Institution (BSI) progress on this front.

1. • A new device is helping cancer patients with hair loss following their chemotherapy treatments.

1. • Survey results from Team-NB found close to half (46 percent) of notified bodies do not intend to apply for designation under the European in vitro diagnostic regulation (IVDR). Get a deeper dive on this news here. 

1. • In the lead up to Brexit, the Medicines & Healthcare products Regulatory Agency (MHRA) has granted medical device manufacturers extension options to obtain new 'CE' markings for their products.

1. • The shutdown of the U.S. Federal Government is over for now, but here’s a look back at its potential impact on our industry.

1. • Turkey has announced plans to align its medical device regulations with the European Union.

1. • The FDA is making cybersecurity for medical devices a focal point of its ongoing work.

January 25, 2019

356. That’s the remaining number of days at your disposal to make this year truly dynamic. If not approached or managed strategically, you’re at risk squandering this valuable time and falling behind.

And less than two weeks into 2019, the medical technology field is already facing reports of potential delays from the European Union’s new rules, wondering how artificial intelligence will continue shaping its future, and preparing for the FDA’s modernization of its review process.
 
Launching today to keep you ahead of the game, Cogent Corner is a resource to inform medical device manufacturers, innovators and leaders of the most pertinent regulatory updates and industry news. The information offered by Cogent Corner will help you play a vital role in improving the efficiency healthcare, and continue making products that serve more patients across more countries.

By staying knowledgeable and vigilante in their pursuit of real time information, medical device manufacturers ensure their contributions will enter the market, and reach users who need them the most.