How do you align your clinical strategy so that the evidence supports the regulatory requirements of your target markets?
We align Clinical & Medical Affairs around the regulatory endpoints: from clinical strategy and evidence planning through clinical evaluation to interaction with authorities, for pharma, biotech, MedTech and IVD. The real sticking point is rarely the study design, it is the handover: anyone who fails to plan clinical data from the outset so that it can be used for the clinical evaluation and the post-market reports will produce robust results that still have to be reworked from a regulatory perspective.
- Pharma
- Biotech
- MedTech
- IVD
Overview
Which challenges arise in Clinical & Medical Affairs management?
Clinical & Medical Affairs across pharma, biotech, MedTech and IVD · clinical evaluation per MDR Annex XIV and MEDDEV 2.7/1 Rev. 4 · interim staffing of clinical functions
Last updated: 2026-06-13
Clinical Affairs connects the scientific planning of clinical activities with the regulatory requirements of the target markets. The function rarely breaks down over a single document, but rather at the transitions between strategy, evidence and market access. Four points where clinical programs most often get stuck:
- The clinical strategy is not aligned with the regulatory endpoints of the target markets. What the MDR requires via Annex XIV, what the FDA requires via the 510(k) or BLA pathway and what the EMA requires all differ, and the study design and endpoints have to cover these requirements from the outset.
- CRO management ties up internal resources without clear accountability for deliverables. Without defined interfaces and acceptance criteria, technical oversight shifts back into the company while responsibility sits with the service provider.
- Clinical data is not systematically carried over into the clinical evaluation and the post-market reports. Data that cannot be planned from the start for the clinical evaluation per MDR Annex XIV and for PMCF has to be reworked from a regulatory perspective.
- Clinical functions are understaffed during launch phases and after clinical milestones. Vacancies in Clinical and Medical Affairs roles hit programs precisely when analysis, evaluation and interaction with authorities are due in parallel.
Services
How we support you
Clinical Strategy & Evidence Planning
Development of a regulatory-sound overall clinical strategy for market access and post-market. Deliverable: an evidence plan with defined clinical endpoints, study design and evidence requirements, benchmarked against MDR Annex XIV, the FDA 510(k) pathway and the BLA.
Clinical Evaluation & SSCP
Preparation and review of clinical evaluation reports in line with MDR Annex XIV and MEDDEV 2.7/1 Rev. 4. Deliverable: a Clinical Evaluation Report as well as the Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices.
Learn more →Study Planning & Protocol Development
Design of clinical studies and registry protocols for the post-market space. Deliverable: study and registry protocols, support with ethics committee submissions and study registration, as well as alignment with the PMCF requirements under MDR.
Interim Medical & Clinical Affairs
Bridging vacancies in Clinical and Medical Affairs positions with experienced specialists. Deliverable: immediate deployment on ongoing clinical projects, including Medical Scientific Liaison and Medical Advisor tasks on a temporary basis.
How we work together
What it comes down to
Clinical & Medical Affairs rarely fails over the individual study and almost always over the sequence. Three strands have to interlock: the clinical strategy defines which endpoints the target markets require, because the MDR (EU) 2017/745 via Annex XIV, the FDA 510(k) pathway and the BLA call for different evidence. The study planning has to map these endpoints so that the data later not only holds up scientifically but feeds directly into the clinical evaluation. And the clinical evaluation per MDR Annex XIV and MEDDEV 2.7/1 Rev. 4 has to demonstrate that the required safety and performance is covered by exactly this evidence. Anyone who plans the first strand without the third produces data that has to be reworked from a regulatory perspective.
This is precisely where our work comes in: the Strategy and Evidence Assessment makes visible at the outset which endpoint is critical for the respective access pathway, before protocols are written and CRO capacity is committed. The handover to post-market surveillance and PMCF is planned in from the start, not added later: clinical data that is set up from the outset to be usable for the clinical evaluation and the post-market reports closes the gap that would otherwise turn into a vacancy during launch phases and after clinical milestones.
Our approach
Our approach
Step
Result
Strategy & Evidence Assessment
Assessment of the existing clinical strategy against the regulatory endpoints of the target markets, with the evidence needs identified.
Evidence & Study Planning
Evidence plan with defined endpoints, study design and protocols, aligned with MDR Annex XIV and PMCF.
Execution & CRO Oversight
Operational support of the clinical activities with clear interfaces and acceptance criteria towards the CRO.
Clinical Evaluation & Reporting
Clinical Evaluation Report in line with MDR Annex XIV and MEDDEV 2.7/1 Rev. 4, including the SSCP where required.
Interaction with Authorities
Prepared and supported communication with authorities and the notified body in line with the market access requirements.
Post-Market Handover
Clinical data carried over into PMCF and post-market reports, without regulatory rework.
Common pitfalls
Where projects commonly fail
The clinical strategy is set up without reference to the regulatory endpoints of the target markets.
Endpoints and study design have to cover what MDR Annex XIV, the FDA 510(k) or BLA pathway and the EMA require, otherwise the data is scientifically valid but not usable from a regulatory perspective.
The clinical evaluation is started too late.
If the available clinical evidence is insufficient under MDR Annex XIV and the equivalence route is blocked, there is no time left to generate own clinical data, which leads to findings from the notified body.
Clinical data is not planned for reuse.
Anyone who fails to set up studies from the outset so that the results feed into the clinical evaluation and into PMCF under MDR will have to prepare the data for the post-market reports retrospectively.
CRO management runs without defined accountability for deliverables.
Without documented interfaces and acceptance criteria, oversight ties up internal resources while technical responsibility sits ambiguously between client and service provider.
The equivalence route is overestimated for Class IIb and Class III devices.
For higher risk classes, own clinical evidence is regularly mandatory; literature data alone has to be evaluated in a device-specific and methodologically robust manner, otherwise it does not support the clinical evaluation.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): primary text, Annex XIV (Clinical Evaluation & PMCF)
- MEDDEV 2.7/1 Rev. 4: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
- Regulation (EU) 2017/746 (IVDR): primary text, performance evaluation
- Writer material clinical-affairs.md (source material, revised)
- https://theentourage.de/expertise/clinical-affairs/ (existing page content)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Regulation (EU) 2017/745 (MDR)
- MDR Annex XIV (Clinical Evaluation & PMCF)
- MEDDEV 2.7/1 Rev. 4 (Clinical Evaluation)
- Regulation (EU) 2017/746 (IVDR)
- FDA 510(k) (Premarket Notification, 21 CFR 807 Subpart E)
- FDA BLA (Biologics License Application)
Related topics
Clinical Evaluation (MDR / MEDDEV) →
Clinical Evaluation Report per MDR Annex XIV and MEDDEV 2.7/1 Rev. 4 in detail
Clinical Project Management →
Operational management of clinical studies in line with the strategic plan
Post-Market Surveillance →
Connecting clinical data to PMS and PMCF under MDR
CRO Support →
Selection and oversight of CROs with clear accountability for deliverables
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