The 28 members of the Council of the EU unanimously voted to adopt the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), just two weeks after releasing the final texts of the regulations.
The new rules introduce deep changes in the regulatory framework for the marketing of devices and IVDs in Europe, the world’s second-largest device market.
Medical Device Regulation (MDR) final text
http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf

In Vitro Diagnostic Regulation (IVDR) final text
http://data.consilium.europa.eu/doc/document/ST-10729-2016-INIT/en/pdf

Adoption timelines

• EU Council has unanimously voted adoption of the MDR and IVDR on March 7, 2017.
• The European Parliament will then vote to enact the legislation in April, 2017.
• The texts will be published in the Official Journal of the European Union.
• MDR regulations will take full effect in 2020 (after a three-year transition period).
• IVDR regulations will be fully implemented in 2022 (after a 5-year transition period).
• It remains to be seen whether the UK will adopt the MDR and IVDR.

Content of the new legislation

The texts of new regulations include, among several measures:
• new rules to tighten regulation by national authorities of notified bodies,
• stricter post-market surveillance to monitor faulty products,
• increased patient protection during clinical trials, and
• added data requirements for study sponsors.

Preparing for the new rules
Device manufacturers should allocate time and resources to adapt to stricter, more complex requirements.

The new MDR measures include incorporating unique device identifiers (UDI) on all medical device labels. The UDI and other pertinent medical data will be accessed through a revamped European Database for Medical Devices (Eudamed).
In spite of the official timeframes for mandatory implementation, changes already have begun to affect Europe’s Notified Body sector. Manufacturers are likely to have fewer Notified Bodies to choose from and to partner with for CE Mark certification, quality system inspections, and related functions going forward.

Effects On European Authorized Representatives
For foreign manufacturers that have no physical presence in Europe, establishing a partnership with a European Authorized Representative is crucial (and required) for CE Mark certification and successful commercialization.
Authorized Representatives act as liaisons between foreign manufacturers and national Competent Authorities. Authorized Representatives play a major role in dealing with both premarket and postmarket compliance and regulatory issues on behalf of manufacturing clients, and that role will continue under the new MDR and IVDR.
However, one change under the new regulations may have significant ramifications for how quickly or easily foreign manufacturers may find and establish partnerships with Authorized Representatives. Namely, the MDR will hold Authorized Representatives jointly liable, along with manufacturers, in cases where devices sold on the European market are found to be defective.
This change has major implications for foreign manufacturers, as firms offering Authorized Representative services can certainly expect more thorough due diligence and scrutiny from potential Authorized Representative partners who now will incur liability they did not have before. Foreign manufacturers also may undergo additional monitoring by their Authorized Representatives for postmarket compliance.

The Council of the European Union has completed the final versions of the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), which update the regulatory framework for the marketing of devices and IVDs in Europe, the world’s second-largest device market.

After the initial draft was made available in May 2016, the content has been approved by the Council on 20 September 2016. The final versions have been produced after a legal-linguistic review to ensure the texts are coherent and equivalent in all 24 official EU languages.

Adoption timelines
• The EU Council is scheduled to vote adoption of the MDR and IVDR on March 7, 2017.
• The European Parliament will then vote to enact the legislation on March 20, 2017.
• MDR regulations will take full effect in 2020 (after a three-year transition period).
• IVDR regulations will be fully implemented in 2022 (after a 5-year transition period).
• It remains to be seen whether the UK will adopt the MDR and IVDR.

Content of the new legislation
The drafts versions of the new regulations were released in May 2016 and include, among several measures:
• new rules to tighten regulation by national authorities of notified bodies
• stricter post-market surveillance to monitor faulty products,
• increased patient protection during clinical trials, and
• added data requirements for study sponsors.

Preparing for the new rules
In the interim between likely legislative approval in March 2017 and formal implementation in 2020, device manufacturers should allocate time and resources to adapt to stricter, more complex requirements.
The new MDR measures include incorporating unique device identifiers (UDI) on all medical device labels. The UDI and other pertinent medical data will be accessed through a revamped European Database for Medical Devices (Eudamed).

In spite of the official timeframes, changes already have begun to affect Europe’s Notified Body sector. Manufacturers are likely to have fewer Notified Bodies to choose from and to partner with for CE Mark certification, quality system inspections, and related functions going forward.

Effects On European Authorized Representatives
For foreign manufacturers that have no physical presence in Europe, establishing a partnership with a European Authorized Representative is crucial (and required) for CE Mark certification and successful commercialization.
Under Europe’s current medical device and IVD Directives, Authorized Representatives act as liaisons between foreign manufacturers and national Competent Authorities. Authorized Representatives play a major role in dealing with both premarket and postmarket compliance and regulatory issues on behalf of manufacturing clients, and that role will continue under the new MDR and IVDR.

However, one change under the new regulations may have significant ramifications for how quickly or easily foreign manufacturers may find and establish partnerships with Authorized Representatives. Namely, the MDR will hold Authorized Representatives jointly liable, along with manufacturers, in cases where devices sold on the European market are found to be defective.
This change has major implications for foreign manufacturers, as firms offering Authorized Representative services can certainly expect more thorough due diligence and scrutiny from potential Authorized Representative partners who now will incur liability they did not have before. Foreign manufacturers also may undergo additional monitoring by their Authorized Representatives for postmarket compliance.

BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), announced that InEk, the German Institute for the Hospital Remuneration System, has awarded NUB Status 1 for the Revivent TC™ TransCatheter Ventricular Enhancement System.

The NUB process supports introduction of new and innovative medical devices in Germany. It allows participating hospitals to receive full reimbursement and a supplemental payment for new technologies in the German reimbursement system. NUB Status 1 is the highest priority designation available, and was only assigned to a small minority of product submissions for 2017.

“Achieving NUB Reimbursement Status 1 is an important step towards increasing product adoption in Germany, where there’s a growing need for effective, less invasive, and cost-effective HF treatment options such as Revivent TC,” stated Kenneth Miller, president and chief executive officer of BioVentrix, Inc. “We look forward to working closely with physicians and hospitals to bring this novel therapy to patients suffering from left ventricular dysfunction.”

About BioVentrix and the Revivent TC System

BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive therapies for treating HF. The company recently received CE mark certification for its closed-chest Revivent TC TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. Placement of the Revivent TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled towards one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.

Click here for corporate video with animation

Note: The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States.

Contact: David Schickling, VP of Sales and Marketing, +1-925-830-1000.

With the completion of the acquisition, Boston Scientific will integrate certain manufacturing assets and biologic tissue capabilities into its structural heart business for use in the manufacturing of the Lotus™ Valve System* and future heart valve technologies.
The two organizations announced a definitive agreement for Boston Scientific to acquire the advanced biologic tissue capabilities and make a 15% equity investment in Neovasc, for a total of $75 million in cash.
With the equity investment, Boston Scientific now beneficially owns, controls and directs 11,817,000 common shares representing in aggregate 15% of the issued and outstanding common shares which were acquired at a price of US$0.60 per common share for total consideration paid of US$7,090,200.1
The common shares were acquired for investment purposes. Prior to these transactions, Boston Scientific did not beneficially own, control or direct any common shares of Neovasc.

Read more: streetinsider.com

 

Amaranth Medical, a privately held medical device company, announced the initiation of a clinical study of the Company’s latest-generation MAGNITUDE™ sirolimus-eluting bioresorbable scaffold (BRS) scaffold, which has a strut thickness in the sub-100-micron range. Dr. Antonio Colombo, director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and Dr. Juan F. Granada, executive director and chief innovation officer of the CRF-Skirball Center for Innovation will serve as co-primary investigators.

“Cardiologists are really asking for thin-walled scaffolds displaying the performance, efficacy and safety profile of metallic drug eluting stents,” noted Dr. Juan F. Granada. “The introduction of devices with this profile could broaden the spectrum of treatment with fully bioresorbable scaffolds. Amaranth’s 115-micron APTITUDE™ scaffold and their next generation MAGNITUDE scaffold promise to achieve those objectives, as Amaranth’s thinner strut design has the potential to provide the perfect balance between deliverability, over-expansion capabilities and long-term mechanical stability.”

This study, called RENASCENT-III, will enroll approximately 70 patients with symptomatic coronary artery disease in centers in Italy and Colombia, South America. Following implantation of the MAGNITUDE scaffold, participants in will be evaluated at nine and 24 months and up to five years.

 

Read more: Renascent-III Trial