Medical devices

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Practice notes
Rome II—application and interpretationThis Practice Note is for use when determining applicable law in respect of events giving rise to damage, where...
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19th May
Q&As
Can a third party rely on ostensible/apparent authority where they know the person signing a document is an employee of a company not a director and...
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19th May
Practice notes
Brexit—exiting the EU under Article 50 [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note contains...
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Produced in partnership with Adam Cygan of University of Leicester 19th May
Practice notes
Antibiotic drug Nitrofurantoin (AMCo, Morningside Healthcare, Morningside Pharmaceuticals and Alliance Healthcare) (50507)CASE HUB See further,...
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19th May
Q&As
Can the board of a co-operative and community benefit society (a registered society) delegate powers to any third party, and can the registered...
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19th May
Practice notes
Rome Convention—introduction and interpretation [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.The UK is no longer...
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19th May
Precedents
Coronavirus (COVID-19): In addition to the below content on force majeure generally, see also: • Coronavirus (COVID-19)...
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19th May
Practice notes
Many companies and government bodies (such as HMRC) have been exposed to loss of confidential information and many other breaches of confidentiality...
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19th May
Practice notes
Introduction to retained EU lawThis Practice Note provides an introduction to retained EU law. It provides an overview of the key definitions and...
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Produced in partnership with Dr. Kieran Laird of Gowling WLG 19th May
Precedents
1 Counterparts—agreement 1.1 This agreement may be signed in any number of separate counterparts, each of which when...
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19th May
Practice notes
Model ADR clausesThis Practice Note considers model form alternative dispute resolution (ADR) clauses provided by a number of service providers,...
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19th May
Precedents
Option 1—contract signed on behalf of a company, where the authorised signatory is an individual Signed by [insert name of...
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19th May
Practice notes
Requirements of the company sealThis Practice Note provides practical guidance regarding the requirements of the company seal. Where a company has a...
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19th May
Practice notes
Brexit implementation period—enforcement [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note considers...
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19th May
Practice notes
SubcontractingThis Practice Note examines the following legal and practical matters in relation to entering into a subcontract or when granting...
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19th May
Practice notes
ScopeThis Practice Note explains trade mark law on parallel trade. Parallel imports, or ‘grey market’ goods, are genuine goods that are placed on the...
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Produced in partnership with Taylor Wessing LLP 19th May

Most recent Medical devices content

Practice notes
The EU MDR and IVDR implementing acts and guidance trackerThis Practice Note tracks the progress of implementing acts, guidance and key initiatives to...
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1st Sep
Practice notes
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operatorsThis Practice Note considers the...
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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 BodiesThis Practice...
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Produced in partnership with Alison Dennis of Taylor Wessing LLP 19th Aug
Practice notes
An introduction to the regulation of medical devices—EU Directives regimeIn the EU, medical devices are tightly regulated by laws that govern their...
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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 RegulationThis Practice Note provides an overview of...
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Produced in partnership with Alison Dennis of Taylor Wessing LLP 17th Aug
Precedents
Medical devices due diligence questionnaireIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred...
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17th Aug
Practice notes
Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...
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Produced in partnership with Alison Dennis of Taylor Wessing LLP 17th Aug
Precedents
Medical devices—transitioning to the EU MDR and IVDR—training materialsThese training materials consist of template PowerPoint slides that can be used...
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16th Aug
Practice notes
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
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16th Aug
Practice notes
The regulation of medical software, including mHealth appsIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this...
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16th Aug
Practice notes
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...
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16th Aug
Practice notes
Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...
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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?This Q&A...
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Produced in partnership with Victoria Hewson of Institute of Economic Affairs 1st Aug
Q&As
Why are e-cigarettes subject to the Medicines and Healthcare Products Regulatory Agency regulatory procedures? Are e-cigarettes considered medical...
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31st Jul
Q&As
What are the rules regarding the advertising of medical devices?What constitutes a medical device?A 'medical device' is defined in the Medical Devices...
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Produced in partnership with Sarah MacDonald of Wiggin 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...
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Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 31st Jul

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