In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and
FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7.
Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive scheme. Although no definitions in respect of these prohibited activities have been included in the Medicines Act, considerable guidance as to
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance requirements for devices. ‘Human factors’ refers to how a person uses or interacts with a device taking into account the context and
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR
The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface between personalised medicines and companion diagnostics. Companion diagnostics are defined by the In Vitro Diagnostic Regulation as a medical device which allows
On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing cleaning, disinfection, and sterilization.
Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa. Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices had few legislative and regulatory formalities to comply with.
On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here. Final Adoption of the texts anticipated in March The
On 13 December 2016, the French Decree 2016-1716 implementing the French Law 2016-41 modernising the French healthcare system (“French Law 2016-41”) was adopted. This Decree provides important information concerning the obligation for manufacturers of implantable medical devices and manufacturers of Class III medical devices to submit a summary of product characteristics to the French Agency
Effective January 6, 2017, the U.S. Food and Drug Administration (FDA) reclassified surgical instrumentation for use with urogynecologic surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class I (general controls) devices to class II (special controls) devices. Surgical mesh—and the instrumentation for its administration—have been used for the transvaginal repair of POP since the
In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including
As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and even their own workplace. More and more, mobile devices are also connecting people with one of the places they least want to go: doctor’s offices.
Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step
On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.
On January 26, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Draft Guidance). Read More: FDA Offers New Recommendations for Interoperability of Connected Devices
The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, proponents of the suspension speculate that it may represent a window to full repeal. Read More: Congress Suspends Medical Device Tax for Two
On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC information that should be provided in a premarket submission for electrically-powered medical devices. Read More: New EMC Guidance Released by FDA
On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and data submission for kits. Read More: FDA Offers Clarity of UDI Application to Kits
This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. Read More: When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices
Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product. Slipped within this proposed rule, however,
On September 24, the Food and Drug Administration (FDA) released a final guidance document clarifying the revised custom device exemption implemented in Section 520(b) of the Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. / The final guidance provides helpful clarification of various elements of