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Category Archives: Medical Devices

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The MHRA issues new guidance concerning Own Brand Labelling or “Virtual Manufacturing”

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

French Sunshine Regulations: The Puzzle Now Completed and in Force

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

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are out

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

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

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[1].  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

FDA: Implementation of Amended Intended Use Regulations Delayed Until March 21, 2017

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

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“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

FDA Strengthens Requirements for Surgical Instrumentation Used with Urogynecologic Surgical Mesh

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

ANSM on the de-notification or termination of notified bodies’ activities

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

The European Medicines Agency issues an opinion on the principal mode of action of proanthocyanidins present in cranberry extracts

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.

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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

Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications

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

Medical Device Alert – The European Commission published a revised MEDDEV on the classification of stand alone software as medical device

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

Medical Device Alert – The European Commission published a revised MEDDEV on Clinical Evaluation of Medical Devices

On 29 June 2016, the European Commission issued a much-awaited new version of the MEDDEV 2.7/1 entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/385/EEC“. This revision substantially amplifies the previous version of the MEDDEV which was published in September 2009. It also provides detailed guidance on the steps

Adoption of the French Government Order Relating to Study Involving Human Persons Pursuant to the Public Health Law Dated 26 January 2016

Regulation No. 536/2014 repealed Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The main purpose of the Regulation is to harmonize and simplify

Mobile medical apps are a form of medical device — and are regulated as such

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.

Medical Device Alert – Political Agreement Concerning the Text of the new Regulations on medical devices and in vitro diagnostic medical devices

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

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

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.

Government Contractors Interested in Inverting: Stay Tuned

The U.S. Treasury Department issued temporary regulations last week – effective Friday, April 8 – that change the landscape for U.S. companies interested in “inverting,” as we reported here. Corporate inversion is the general term for a number of transactions, including a merger that has the effect of relocating a U.S. corporation’s legal domicile to a country with a lower tax rate.

NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators.  The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device