Medical devices

Practice notes

The EU MDR and IVDR implementing acts and guidance tracker

The EU MDR and IVDR implementing acts and guidance trackerThis Practice Note tracks the progress of implementing acts, guidance and key initiatives to...

1st Sep

Practice notes

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operatorsThis Practice Note considers the...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 19th Aug

Practice notes

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified BodiesThis Practice...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 19th Aug

Practice notes

An introduction to the regulation of medical devices—EU Directives regime

An introduction to the regulation of medical devices—EU Directives regimeIn the EU, medical devices are tightly regulated by laws that govern their...

Produced in partnership with Jane Summerfield of Hogan Lovells, Elisabethann Wright BL of Cooley (UK) LLP and Fabien Roy of Hogan Lovells 19th Aug

Practice notes

Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices RegulationThis Practice Note provides an overview of...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 17th Aug

Precedents

Medical devices due diligence questionnaire

Medical devices due diligence questionnaireIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred...

17th Aug

Practice notes

Clinical evaluation and performance evaluation of medical devices in the EU

Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 17th Aug

Precedents

Medical devices—transitioning to the EU MDR and IVDR—training materials

Medical devices—transitioning to the EU MDR and IVDR—training materialsThese training materials consist of template PowerPoint slides that can be used...

16th Aug

Practice notes

The regulation of medical devices in the UK

The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...

16th Aug

Brexit

Practice notes

The regulation of medical software, including mHealth apps

The regulation of medical software, including mHealth appsIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this...

16th Aug

Practice notes

What does IP completion day mean for medical devices?

What does IP completion day mean for medical devices?11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to...

16th Aug

Practice notes

Post-market surveillance of medical devices in the EU

Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...

Produced in partnership with Alison Dennis of Taylor Wessing LLP 16th Aug

Q&As

What is the UK Conformity Assessed product mark and what does it mean for manufacturers selling products in the UK and the EU after Brexit?

What is the UK Conformity Assessed product mark and what does it mean for manufacturers selling products in the UK and the EU after Brexit?This Q&A...

Produced in partnership with Victoria Hewson of Institute of Economic Affairs 1st Aug

Brexit

Q&As

Why are e-cigarettes subject to the Medicines and Healthcare Products Regulatory Agency regulatory procedures? Are e-cigarettes considered medical devices and/or medicinal products?

Why are e-cigarettes subject to the Medicines and Healthcare Products Regulatory Agency regulatory procedures? Are e-cigarettes considered medical...

31st Jul

Q&As

What is the regulatory framework applicable to the use of a medical device which is under development (ie not yet CE marked) for research use only as part of a clinical study or research collaboration? How can the device manufacturer ensure that the device is used solely for research and not clinical use?

What is the regulatory framework applicable to the use of a medical device which is under development (ie not yet CE marked) for research use only as...

31st Jul

Q&As

What are the rules regarding the advertising of medical devices?

What are the rules regarding the advertising of medical devices?What constitutes a medical device?A 'medical device' is defined in the Medical Devices...

Produced in partnership with Sarah MacDonald of Wiggin 31st Jul

Q&As

Are you aware of any databases for: (i) a European regulatory body for medical devices for human application from which technical information about devices seeking approval can be obtained, (ii) obtaining a copy of the application if a medical device manufacturer has applied for authorisation for use in Europe? In the US, medical device manufacturers must submit a detailed application to the Food and Drug Administration (FDA). The application to the FDA is referred to as ‘510K’ filing. Is there a European equivalent where such information can be found?

Are you aware of any databases for: (i) a European regulatory body for medical devices for human application from which technical information about...

31st Jul

Q&As

Would a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease be considered as a medical device or a medicinal product?

Would a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease...

31st Jul

Q&As

Would an app designed to aid clinicians to calculate the risk of patient deterioration and likelihood of developing sepsis be considered a medical device and as such require registration with the MHRA? If so, what class of device would it fall into under the Medical Devices Regulations 2002?

Would an app designed to aid clinicians to calculate the risk of patient deterioration and likelihood of developing sepsis be considered a medical...

31st Jul

Q&As

What action can a Member State competent authority take in the event that they discover a non-compliance during an inspection of a medical device manufacturing facility?

What action can a Member State competent authority take in the event that they discover a non-compliance during an inspection of a medical device...

Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 31st Jul

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