CAMD publishes roadmap on the implementation of the MDR and IVDR
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 simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).
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
The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of
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.
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.
On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices.
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.
In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a press release signalling that it will not be left behind on the action when it launched a probe into
On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance, which is expected to have substantial consequences for the current arrangements between Own Brand Labellers (OBL) and “Original Equipment Manufacturers” (OEM), is
The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of
The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH), the FDA center that governs medical devices, reached an 8 year low, down 50% from FY 2015.
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 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. Background The Sunshine Act imposes a
On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of tobacco products as drugs, devices, or combination products. That rule, which also amended the intended use regulations for drugs and devices, was to go into effect today, February 8, 2017; however, implementation
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
On 14 November 2016, the French National Agency for Medicines and Health Products Safety (“ANSM”) issued the English version of an information bulletin and a Q&A document concerning the consequences of de-notification or termination of notified bodies’ (“NB”) activities, dated 24 October 2016. Background The ANSM notes that in recent months, several notified bodies have
On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) concerning the principal mode of action of proanthocyanidins present in cranberry extracts and included in products intended to be used by their manufacturers for prevention and treatment of urinary tract infections.
On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.” This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order
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
On 15 July 2016, the European Commission issued a revised version of MEDDEV 2.1/6 entitled “Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices“. This new document is intended to replace the original version of MEDDEV 2.1/6 which was issued in January 2012. The