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Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 1, 2020

Your guide to the latest Hill developments, news narratives, and media headlines provided by the Hogan Lovells Government Relations and Public Affairs team. In Washington: Senate Republicans are beginning to put together their own fifth COVID-19 aid package, but with no apparent Democratic involvement it’s unlikely to receive enough support to pass both chambers, according to

Department of Defense Lists Chinese Companies, with Chinese Military Ties, Operating in the United States

On 24 June 2020, the United States Department of Defense made public a list of Chinese companies operating in the U.S. that are associated with the Chinese military. The Department of Defense has been legally required to maintain such a list under Section 1237 of the 1999 National Defense Authorization Act. The Act requires the

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 28, 2020

Your guide to the latest Hill developments, news narratives, and media headlines provided by the Hogan Lovells Government Relations and Public Affairs team. To read our recent client alert “House and Senate considering bills to enhance flexibility for PPP borrowers” click here. This is a revision of the May 22 client alert, which was updated due

Bill Introduced to Block Chinese Acquisitions During COVID-19 Pandemic

Representative Jim Banks introduced a bill on 5 May 2020 to “place temporary restrictions on acquisitions [of U.S. companies] by the People’s Republic of China. . .” during the COVID-19 pandemic. The bill would mandate, with certain exceptions, that the Committee on Foreign Investment in the United States (CFIUS) review, and the President deny, certain

Update on UK export licencing processes amidst the COVID-19 outbreak

Amidst the global COVID-19 pandemic many things are uncertain. For businesses, this is further compounded by the rapidly changing and temporary measures that governments are launching to limit the financial fallout of the outbreak. To ensure businesses are not accidently caught out by these new measures, it is important for companies importing and exporting goods

Engage is coming: A new home for Medical Devices, Pharmaceutical & Biotechnology News!

Dear reader, On December 2, we will begin publishing all content related to Medical Devices, Pharmaceutical, and Biotechnology regulations on our new knowledge platform: Hogan Lovells Engage.  We are gradually moving all other blog content to Engage as well, but while we are making this transition, you will continue to be able to find all

The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices. The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. The

Equator Principles – Sustainable Infrastructure Projects for Future Generations

The construction and further development of infrastructure is of crucial importance for society and a healthy economy. But protecting the environment and human rights has also come to the forefront of the global agenda. At times these two goals have been cast as mutually exclusive, but the financing community has recognized the imperative to harmonize

Appetite for anti-unfair competition action in the Internet space

It’s been almost a year since the new “Internet clause” in China’s Anti-Unfair Competition Law (AUCL) is in force. The enforcement authority hasn’t used it much in 2018. But one decision is noteworthy. AUCL amendment On 1 January 2018, the first amendment to the AUCL since its enactment in 1993 came into effect. One of

New EU draft guidelines on clinical trials with ATMPs open for consultation

The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”). The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions

On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and all EU Member States to have an urgent discussion concerning the timelines for the application of the Medical Devices Regulation (MDR) and In Vitro

LawTech in London! New court – read the latest from our Global Products Law Team

In a move to cement London’s reputation as “the” global legal centre, on 4 July 2018 a new flagship court was announced by Lord Chancellor David Gauke.  The new court will specialise in (among other things) cybercrime, fraud and economic crime.  This is heavy investment to ensure that the UK remains the centre for tech-based

Clinical trials: Digital technology for recruitment, consent, and data capture

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is transferred from the clinical trial sites (hospitals/HCPs) to the sponsor (i.e. pharma or device company) is transmitted in electronic form.

Digital Health: CE marking of medical devices

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.

CFDA Continues to Expand Oversea Inspection

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for the following eight international medical device manufacturers under its Medical Device Good Manufacturing Practice.

The HPRA published a MDR/IVDR Guide for Distributors of Medical Devices

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).