Insights : sector - Osborne Clarke

Life Sciences and Healthcare

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Article list

Regulatory and compliance

Future Foods Take-away | Brussels’ beef with plant-based food names

The alternative foods sector awaits with uncertainty for an outcome from the next round of EU talks on meat names...

05/02/2026

Read time 5m

Life Sciences and Healthcare

EU device package envisages more support for 'orphan' and breakthrough products and flexible access in crises

In-house exemptions, 'orphan grandfathering', 'sandboxes' and crisis derogations aim to balance unmet needs with safety

04/02/2026

Read time 8m

Life Sciences and Healthcare

Draft EU medtech revisions adjust importer and distributor roles to support supply chain resilience

Digital obligations, leaner repackaging rules and new shortage reporting tools may evolve supply chain responsibilities

30/01/2026

Read time 7m

Life Sciences and Healthcare

Data-driven digital health businesses challenged with balancing AI advances and tighter regulation in 2026

Hyper-personalisation, data interoperability and AI are among 2025's fast-evolving areas to continue to watch this year

29/01/2026

Read time 7m

Life Sciences and Healthcare

EU MDR and IVDR poised to remain main framework for medical AI in draft AI interface reforms

Lex specialis treatment, integrated notified body reviews and clarified duties are designed to limit overlapping regulation of medical AI

28/01/2026

Read time 6m

Life Sciences and Healthcare

EU digital by default medtech plans signal shift in submissions, product information and online sales

E-submissions, digital documentation and clarified Eudamed and UDI duties to steer medtech towards fuller digitalisation

23/01/2026

Read time 6m

Life Sciences and Healthcare

Planned EU medtech changes and codified Helsinki procedure support consistent qualification and classification

EU coordination, expert panel opinions and targeted down classification are proposed to harmonise risk based outcomes

21/01/2026

Read time 7m

Corporate

Confidence in a changing global market: 2025 dealmaking themes and 2026 market opportunities

The global transactional market demonstrated resilience amid complexity in 2025 as it staged a measured recovery

21/01/2026

Read time 2m

Life Sciences and Healthcare

What will shape European life sciences and healthcare in 2026?

There will be comprehensive regulatory changes across the UK and EU, with streamlined approval pathways alongside heightened governance and compliance...

21/01/2026

Read time 11m

Life Sciences and Healthcare

EU drug agency to take broader coordinating role in devices and diagnostics in latest proposal

Expert panel support, shortage coordination and combined study procedures strengthen the EMA's oversight of devices

20/01/2026

Read time 6m

Life Sciences and Healthcare

Revised EU medtech regulations proposal sharpens software and cybersecurity rules for digital health

Down‑classification, established software concepts and cyber-incident reporting could reshape digital medtech compliance

15/01/2026

Read time 7m

Regulatory Outlook

Products | UK Regulatory Outlook January 2026

General/digital products UK: Product Regulation and Metrology Act consultations and guidance | Government response to the independent review of the...

13/01/2026

Read time 19m

Life Sciences and Healthcare

Proposed EU medtech laws seek more predictable and efficient notified body oversight

Structured dialogue, streamlined sampling, extended audits and SME‑friendly fees to reshape device conformity assessment

13/01/2026

Read time 8m

Digital Regulation

Simplification for AI Medical Devices?

How the European Commission’s proposal on amending the MDR and IVDR adds to the simplification efforts by the Digital Omnibus...

12/01/2026

Read time 1m

Life Sciences and Healthcare

EU revised device rules rebalance compliance towards simplification and proportionality

Commission proposal would streamline MDR and IVDR duties with flexible evidence, timeless certificates and tailored risk rules

09/01/2026

Read time 9m

View all insights

Regulatory and compliance

Future Foods Take-away | Brussels’ beef with plant-based food names

The alternative foods sector awaits with uncertainty for an outcome from the next round of EU talks on meat names...

05/02/2026

Read time 5m

Life Sciences and Healthcare

EU device package envisages more support for 'orphan' and breakthrough products and flexible access in crises

In-house exemptions, 'orphan grandfathering', 'sandboxes' and crisis derogations aim to balance unmet needs with safety

04/02/2026

Read time 8m

Life Sciences and Healthcare

Draft EU medtech revisions adjust importer and distributor roles to support supply chain resilience

Digital obligations, leaner repackaging rules and new shortage reporting tools may evolve supply chain responsibilities

30/01/2026

Read time 7m

Life Sciences and Healthcare

Data-driven digital health businesses challenged with balancing AI advances and tighter regulation in 2026

Hyper-personalisation, data interoperability and AI are among 2025's fast-evolving areas to continue to watch this year

29/01/2026

Read time 7m

Life Sciences and Healthcare

EU MDR and IVDR poised to remain main framework for medical AI in draft AI interface reforms

Lex specialis treatment, integrated notified body reviews and clarified duties are designed to limit overlapping regulation of medical AI

28/01/2026

Read time 6m

Life Sciences and Healthcare

EU digital by default medtech plans signal shift in submissions, product information and online sales

E-submissions, digital documentation and clarified Eudamed and UDI duties to steer medtech towards fuller digitalisation

23/01/2026

Read time 6m

Life Sciences and Healthcare

Planned EU medtech changes and codified Helsinki procedure support consistent qualification and classification

EU coordination, expert panel opinions and targeted down classification are proposed to harmonise risk based outcomes

21/01/2026

Read time 7m

Corporate

Confidence in a changing global market: 2025 dealmaking themes and 2026 market opportunities

The global transactional market demonstrated resilience amid complexity in 2025 as it staged a measured recovery

21/01/2026

Read time 2m

Life Sciences and Healthcare

What will shape European life sciences and healthcare in 2026?

There will be comprehensive regulatory changes across the UK and EU, with streamlined approval pathways alongside heightened governance and compliance...

21/01/2026

Read time 11m

Life Sciences and Healthcare

EU drug agency to take broader coordinating role in devices and diagnostics in latest proposal

Expert panel support, shortage coordination and combined study procedures strengthen the EMA's oversight of devices

20/01/2026

Read time 6m

Life Sciences and Healthcare

Revised EU medtech regulations proposal sharpens software and cybersecurity rules for digital health

Down‑classification, established software concepts and cyber-incident reporting could reshape digital medtech compliance

15/01/2026

Read time 7m

Regulatory Outlook

Products | UK Regulatory Outlook January 2026

General/digital products UK: Product Regulation and Metrology Act consultations and guidance | Government response to the independent review of the...

13/01/2026

Read time 19m

Life Sciences and Healthcare

Proposed EU medtech laws seek more predictable and efficient notified body oversight

Structured dialogue, streamlined sampling, extended audits and SME‑friendly fees to reshape device conformity assessment

13/01/2026

Read time 8m

Digital Regulation

Simplification for AI Medical Devices?

How the European Commission’s proposal on amending the MDR and IVDR adds to the simplification efforts by the Digital Omnibus...

12/01/2026

Read time 1m

Life Sciences and Healthcare

EU revised device rules rebalance compliance towards simplification and proportionality

Commission proposal would streamline MDR and IVDR duties with flexible evidence, timeless certificates and tailored risk rules

09/01/2026

Read time 9m

View all insights

Will James

Partner, International Life Sciences and Healthcare Sector Co-Leader

+44 207 105 7774 Email Will Full bio

Dr. Andrea Schmoll

Partner, International Life Sciences and Healthcare Sector Co-Leader

+49 221 5108 4408 Email Andrea Full bio

Thomas Devred

Partner, Head of Life Sciences and Healthcare - Paris

+ 33 1 84 82 41 06 Email Thomas Full bio

Silvia Steiner

Partner

+34 93 419 18 18 Email Silvia Full bio

Maria Grazia Medici

Partner, Head of Life Sciences & Healthcare

+39 06 3269 5015 Email Maria Grazia Full bio

Herke van Hulst

Partner, Lawyer

+31 207 02 86 72 Email Herke Full bio

Catherine Wolfenden

Partner, Disputes & Risk Practice Group Head

+44 117 917 3600 Email Catherine Full bio

Marcus Vass

Partner, Head of Digital Health

UK +44 2071 057 634 Email Marcus Full bio

Rafael García del Poyo

Partner

+34 91 576 44 76 Email Rafael Full bio

Peter Rudd-Clarke

Partner

+44 207 105 7315 Email Peter Full bio

Tim Harris

Partner

+44 207 105 7144 Email Tim Full bio

Giulia Verusio

Senior Associate

+39 06 3269 5008 Email Giulia Full bio

J. Carlos Suárez

Counsel

+39 02 5413 1772 Email J. Carlos Full bio

David Haex

Co-Managing Partner

+32 2 515 9322 Email David Full bio

Xavier Pican

Partner, IP/IT/Data

+33 1 84 82 45 88 Email Xavier Full bio

Julia Kaufmann, LL.M.

Partner

+49 89 5434 8068 Email Julia Full bio

Dr Flemming Moos

Partner, Specialist lawyer for IT law

+49 40 55436 4054 Email Flemming Full bio

Dr Tim Reinhard

Partner, Head of Intellectual Property Germany, Wirtschaftsmediator (MuCDR)

+49 89 5434 8024 Email Tim Full bio

Dr Martin Sundermann

Partner, Wirtschaftsmediator (MuCDR)

+49 89 5434 8026 Email Martin Full bio

Steve Wilson

Managing Partner

+1 917 545 3672 Email Steve Full bio

Jordi Casas

Co-Managing Partner

+34 93 419 18 18 Email Jordi Full bio

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Life Sciences and Healthcare

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