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New European regulations for medical devices and IVDs set to enter into force in May 2017

European Commission officials provided an update about the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) during the Eudamed Steering Committee meeting of 14 December 2016. There have been discussions concerning the translation of the new Regulations, but the parties involved have been able to avoid the re-opening of formal negotiations. The Commission has presented the following schedule: End of January 20...

Mexico’s COFEPRIS allows Third Party Reviewers (TPRs) to access stalled medical device registrations

The Mexican health authority COFEPRIS has started to allow Third Party Reviewers (TPRs) to access premarket registrations that have stalled under the standard review system. After obtaining authorization from a Mexico Registration Holder (MRH), TPRs may review their registration applications and then submit them back to COFEPRIS for final approval. The new process also covers modifications and renewals, but does not apply to registrations submi...

French Competent Authority ANSM provides indications for manufacturers whose Notified Bodies are de-notified or stop operating.

New recommendations and procedures for manufacturers whose Notified Bodies terminate CE certification and auditing support have been issued by the French National Agency for the Safety of Medicines and Health Products (ANSM). Such manufacturers may obtain marketing extensions for their devices until they find support by a new Notified Body. According to the ANSM, companies whose Notified Bodies become denotified may continue marketing their de...

FDA Adopts Proposals by the IMDRF for the Clinical Evaluation of Software as Medical Device

The proposals by the International Medical Device Regulators Forum (IMDRF) regarding the clinical evaluation of software as a medical device have been incorporated into a new draft guidance by the US Food and Drug Administration. In a document issued in August 2016, the IMDRF proposed some specific clinical evaluation processes for software as a medical device (SaMD) in order to determine safety, effectiveness and performance. Clinical evaluat...

UDI requirements for “Convenience Kits” revised by FDA

The US FDA has changed the definition of “convenience kits” -two or more medical devices packaged together- in terms of Unique Device Identification (UDI) requirements. According to the new draft guidance, a convenience kit consists of two or more devices sold in a single package for convenience; no additional processing or modification of the devices may occur before their use by patients or users. UDI numbers must be reported only on package ...

Final rule for clinical trial information Reporting in the US

In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies how to submit information related to clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule specifies which trials must be submitted, when they must be submitted, and whether compliance has been achieved. The definition of an Applicable Clinical Trial is provided, along with the criteria for determining which studie...

FDA Extends UDI Deadline for Convenience Kit and Repackaged Device Labelers

Labelers of some Class II devices have been notified by the FDA that their deadline for Unique Device Identification (UDI) compliance has been extended to September 2018. The new compliance date for UDI labeling, as well as Global Unique Device Identification Database (GUDID) compliance, is September 24, 2018. The following three categories of devices are involved: “Convenience kits”: two or more devices (Class II or Class I and II in comb...

FDA has released a draft guidance document - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance document entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” This document is intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more c...

FDA Draft Guidance on software changes: tips on how to be compliant with regulations

FDA has published a new draft guidance regarding software changes into an existing device. This document is the result of Agency decision to separate software changes regulations from other devices. This guidance shows FDA commitment in acquiring better awareness on issues related to software products. This document provides details regarding the regulatory requirements which will have been satisfied. The aim of this guidance is both to support...

Final FDA Guidance on Medical Device Electromagnetic Compatibility (ECM)

FDA has finalized a guidance on how manufacturers of electrically powered devices should prove Electromagnetic Compatibility for premarket clearance and approval. Electrically powered devices include those that are battery powered and active implantable devices. According to this guidance Electromagnetic Compatibility is defined as the ability of device to function safely and effectively in its intended electromagnetic environment. The final ...

New version of MEDDEV 2.7/1 on Clinical Evaluation of Medical Devices

MEDDEV guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on Medical Devices. They are not legally states but they reflect the positions taken by various interested parties (Competent Authorities, Manufacturers and Notified Bodies) in the medical devices sector. Among the most relevant guidelines, there is the MEDDEV 2.7-1, entitled Clinical Evaluation: a guide for manufacturers and Notified bodies. ...

Brexit and medical devices: what will change?

On June 23 UK voters decided to leave European Union and because of this many medical devices companies are wondering how Brexit will affect the regulation of devices and IVDs sold in the country. The MHRA (Medicines and Healthcare Products and Regulatory Agency) issued a statement in which they say that they will keep doing their work as usual because until the final breakup, British regulations remain aligned with European rules and CE marked ...

Final guidance from FDA on ISO 10993-1 and biological evaluation of medical devices

FDA has published a final guidance on the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. The document specifically covers the use of ISO 10993-1 but also relevant to other biocompatibility standards ( other parties of ISO 10993; USP; ASTM; ICH) FDA guidance on ISO 10993-1 has not been updated since 1995. The novelty of final version is that manufacturers should perf...

FDA’s final guidance on Post-Market Surveillance

FDA has published a final guidance regarding post-market surveillance requirements, based on Section 522 of US Federal Food, Drug and Cosmetic Act. This final version authorizes the FDA to require post-market surveillance Plan for Class II and Class III devices, which could cause serious adverse events; which are used in pediatric population, which are intended for implantation in humans for more than one year and which are intended for life- s...

Medical devices: EU reached a deal on new rules

The Netherlands presidency of the European Council and representative of the European Parliament agreed new rules on medical devices and in vitro diagnostic medical devices. The agreement, which is still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee, will endorse mid-June 2016. The new rules will apply three years after publication as regards medical devices and five years after p...

New FDA’s draft guidance: Electronic Health Record Data in Clinical Investigations

FDA has published a new draft guidance on Electronic Health Record Data to support the parties, likes sponsors, clinical investigators, contract research organizations and institutional review boards, which are interested on FDA- regulated clinical investigations. The aim of this guidance is to outline which quality and integrity requirements the EHR data have to meet in order to be compliant during FDA’s on-site inspections and audits. This dr...

New FDA’s draft guidance for 3D- printed medical devices

FDA has published a new draft guidance on Additive Manufacturing, also known 3D printing, which is a process that creates a three-dimensional object by building successive layers of raw materials. Each new layers is attached to the previous one until the object is complete. Because of the innovative application of 3D-printed medical devices, this FDA’S draft guidance outlines technical considerations associated with the Additive Manufacturing an...

UK: MHRA has published a new guideline about borderline products

Management of borderline products is a topic issue for manufacturers and Competent Authorities. The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a new guideline to provide more details about the classification of borderline products and the applicable regulations. The guideline address the most common questions of manufacturers, details MHRA position and provide the overview of UK and European legislation. The aim of...

Mobile Health App: US Federal Trade Commission with FDA releases a New Tool

The Us Federal Trade Commission (FTC), upon FDA’S request, has designed the “Mobile Health Apps Interactive Tool” to help developers of mobile medical apps to know which laws their products should be compliant with. The aim of this tool is to ensure the design of medical apps which could help patients and consumers to better manage and track their health and wellness related activities https://www.ftc.gov/tips-advice/business-center/guidance/mob...

FDA promotes the Library of Medical Device Quality Practices

The FDA’s Library of Quality Practices is a resource that helps medical device professionals to improve the quality of their approaches in the design and manufacturing of medical devices. FDA intends to promote the culture of quality and organizational excellence through CDRH’S 2016/2017 Strategic Priorities. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm?source=govdelivery&utm_medi...

China defines new requirements for clinical trials of medical devices

China Food and Drug Administration (CFDA) plans to enforce new requirements for clinical trials on medical devices, except IVDs. The aim of these new guidelines is to ensure more safety and effectiveness of medical devices. The new guidelines will go into effect on June 2016. http://www.sda.gov.cn/

New mode to request Free Sales Certificate to export medical devices outside European Community Countries

Starting from 1st May 2016 a new mode to request Free Sales Certificate for exporting medical devices outside the European Community will go into effect. It will be mandatory to send requests only by certified email address (PEC): all papers will be in electronic format and the official stamps will be scan and attached to the electronic file. http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb...

A new FDA rule: banning powdered surgeon’s gloves and similar devices to protect patients from unreasonable risks.

FDA is proposing this new rule because powder used on some surgeon’s gloves is considered to be the cause of several injuries, like respiratory allergic reaction, lung inflammation, post-surgical adhesions and death. Because of the impossibility of correcting these risks through a new or update labeling, FDA proposal is to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove....

New FDA draft guidance for interoperable medical devices

FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This draft guidance is not final nor is it in effect at this time, the FDA has extended the comment period for 30 days, until April 28, 2016. The draft guidance, when finalized, will represent the current thinking of FDA o...

FDA New Draft Guidance about Clinical considerations for IDES (Investigational Device Exemptions) for Neurological Devices Targeting Disease Progression and clinical outcomes

FDA developed this draft guidance to assist sponsors who intend to submit an investigational device exemption (IDE) to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centerd outcomes. This new draft guidance is addressed to neurological medical devices that are designated to slow, stop or reverse the progression of disease. It also provides general considerations fo...

New ISO 13485:2016 standard is now published

The new edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, is now published. The new standard provides an effective and comprehensive approach to compliance with the global requirements for a medical device quality management system. The new standard will help manufacturers and service providers comply with medical devices regulation. The new edition of the standard provides...

Sterility Information in Premarket Notification (510(k))

The FDA has issued the Sterility final guidance for submissions of Devices Labeled as Sterile. The scope of this guidance is limited to the review of 510(k)s for devices labeled as sterile that are subject to industrial terminal sterilization processes based on microbial inactivation. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm109897.pdf

EU Mobile Health Guidelines will be developed

The European Commission is developing new guidelines to improve mHealth apps data quality. The working group that the Commission has set up will develop guidelines to assess the validity and reliability of the data that health apps collect and process. The group will hold its first meeting in March 2016. The guidelines are expected to be published by the end of this year. https://ec.europa.eu/digital-agenda/en/news/new-eu-working-group-aims-draf...

NEW Draft Guidance on UDI

The US Food and Drug Administration released a draft guidance document on Unique Device Identification of medical devices. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484092.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery The UDI Rule is intended to create a standardized identification system for medical devices used in the United States that makes it possible to rapidly and defin...

FDA outlines recommendatios on Postmarket Management of Cybersecurity in Medical Devices

The FDA has issued a draft guidance for managing postmarket cybersecurity vulnerabilities for marketed medical devices. Manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like othe...

guidance for industry guidance for industry and FDA staff

The FDA released draft guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf

FDA allows marketing of first prosthetic arm that translates signals from person’s muscles FDA allows marketing of first prosthetic arm that translates signals from person’s muscles

The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm396688.htm

Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. htt...

Clinical trials and transparency: the EU Parliament votes the new Regulation Clinical trials and transparency: the EU Parliament votes the new Regulation

The European Parliament has clearly promoted, with 594 votes in favor, 17 against and 13 abstentions: transparency in clinical trials, may soon become common "law" throughout Europe. The new regulation, in fact, should be definitively approved before the summer, to take effect in 2016. di Redazione AboutPharma And Medical Devices http://www.aboutpharma.com/news/farmaco/trial-clinici-e-trasparenza-si-del-parlamento-ue-al-nuovo-regolamento/

Clinical trials for medical devices

Temas srl - Forum Institute of Management GmbH organize an intensive seminar on "clinical trials on medical devices". Dr. Armando De Vincentiis (CSO-THS-Therapeutic Solutions srl), Eng. Elena Venturelli (Medical Device Advisor Merc srl) and Dr. Antonio Parisi (Director Office VI - Clinical trials on medical devices - Ministry of Health) will be the speakers of the seminar. The Seminar will be held on 2 April 2014. at NH Machiavelli Hotel Via Lazz...

Launch of the Medical Device Single Audit Program (MDSAP) Pilot

The Australian Therapeutic Goods Administration (TGA), Brazil’s ANVISA, Health Canada and the US Food and Drug Administration announced the launch of the MDSAP pilot from January 2014, Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company...