Publications

Hogan Lovells Publications

Harmonizing cybersecurity for medical devices: International collaboration moves forward Medical Device Alert

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical ...

Hogan Lovells Publications

Our FDA Medical Device and Technology compliance team receives ISO 13485 auditor certification Medical Device and Technology Alert

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world,...

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars.

Hogan Lovells Publications

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022...

Publications

Digital Health: CE marking of medical devices Medical Device Alert

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 ...

Hogan Lovells Publications

Digital Health: The issues you need to consider to leverage its full potential in 2018 Life Sciences Team

Technology is changing the way the healthcare industry operates, bringing huge potential for untapped business opportunity. At the same time, with these changes comes a dramatic shift in...

Hogan Lovells Publications

The EU regulatory challenges and liability risks associated with 3-D printed medical devices

In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies.

Blog Post

Excessive pricing in pharmaceutical products attracts the European Commission’s attention Focus on Regulation

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...

Blog Post

The MHRA issues new guidance concerning own brand labelling or "virtual manufacturing" Focus on Regulation

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 ...

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