MDR Consulting for Manufacturers of Class IIa/IIb/III Medical Devices

The challenge

The MDR has significantly raised the requirements for technical documentation of Class IIa, IIb and III medical devices. What was accepted under the MDD often no longer meets today’s expectations of Notified Bodies.

For small and medium-sized manufacturers, this creates a double burden: requirements are increasing, but internal resources remain the same. What’s missing isn’t the will to comply — it’s the capacity and specialised knowledge to prepare documentation that is audit-ready.

This is exactly where I come in. I take on the regulatory tasks your team cannot cover — and deliver documents your Notified Body will accept.

My services

Technical Documentation under MDR Annex II and III

The technical documentation is the foundation of your certification. I support manufacturers in building new documentation or revising existing documentation to meet the requirements of MDR Annex II and III.

This includes, among other things:

• Device description and specifications
• Description of the manufacturing process
• Risk management
• Post-market surveillance (PMS)
• Summary of Safety and Clinical Performance (SSCP)
• Labelling and Instructions for Use (IFU) — regulatory review
• Coordination of individual documentation elements into a consistent whole

My focus is not on creating documents for their own sake. Every document must hold up under review by the Notified Body.

Risk Management Documentation

Notified Bodies expect risk management that does not exist in isolation from the rest of the documentation, but is consistently linked — with the clinical evaluation, the intended purpose, and post-market data.

I support with:

• Building or revising the risk management file in accordance with ISO 14971
• Ensuring traceability between risk management, clinical evaluation, and post-market surveillance
• Benefit-risk assessment based on robust data
• Documentation that shows how residual risks are evaluated and accepted

Support for Initial and Re-Certification

The path to MDR certification for Class IIa/IIb/III devices is demanding. I support manufacturers who are either certifying for the first time or transitioning their existing certification to the MDR.

Specifically:

• Gap analysis: Where does your documentation stand, what is missing?
• Prioritisation: Which documents need to be revised first?
• Creation or revision of the identified gaps
• Review of the overall documentation for consistency and completeness

I don’t replace your Regulatory Affairs lead — I complement your team where specialised capacity is lacking.

Audit Preparation

An audit by the Notified Body is approaching — and you’re not sure whether the documentation is ready. This is a situation I see frequently.

I support with preparation:

• Review of documentation to be submitted before the audit
• Identification of weaknesses that are likely to be challenged
• Targeted revision of critical documents
• Review of consistency between clinical evaluation, risk management, and technical documentation

The goal is not perfection on paper. The goal is for your documentation to answer the auditor’s questions before they are asked.

Responding to Notified Body Queries

You’ve received queries from your Notified Body and need support in responding? This is one of the most common reasons manufacturers contact me.

I help with:

• Analysis and interpretation of the queries
• Development of well-founded responses
• Revision of the affected documents
• Alignment of responses to ensure consistency with the overall documentation

When manufacturers contact me

Typical situations where I provide support:

“We have a deadline from the Notified Body and can’t manage it internally.”

Time pressure on regulatory topics is normal. I can step in at short notice and prepare exactly the documents that are needed now.

“We’re transitioning from MDD to MDR and don’t know where to start.”

A gap analysis shows where your existing documentation stands and what specifically is missing. From there, a clear roadmap emerges.

“Our CER was challenged — we need someone with deep expertise in this area.”

Clinical evaluation is my core area. You’ll find details on my clinical evaluation page.

“We don’t have an internal regulatory team for Class IIa/IIb/III.”

Many SMEs don’t have Regulatory Affairs as a separate department. I work as an external specialist directly with your management or quality team.

“The audit is in three months and we’re not sure we’re ready.”

A targeted review of your documentation shows where action is needed — in time before the audit.

Scope: What I don’t offer

Transparency about where my focus lies and where it doesn’t:

• No QMS consulting. I support with technical documentation and clinical evaluation, not with building or certifying your quality management system under ISO 13485.
• No regulatory strategy for entire product portfolios. My focus is on individual devices or device families, not on the strategic regulatory planning of an entire organisation.
• No approvals outside the EU. I advise on the MDR, not on FDA 510(k), NMPA, or other international approval pathways.

This clarity helps both sides: you know what to expect. And I can focus on what I do best.

How I work

Independent, but aligned.

I work my way into your product documentation independently and don’t need daily guidance. At the same time, I provide regular status updates — via email or in short calls.

Fixed price, not hourly rates.

For clearly defined tasks, you receive a fixed-price proposal. No surprise hourly invoices. For ongoing collaboration, we agree on transparent terms.

Documents that are finished.

What I deliver, you can submit directly to your Notified Body. No drafts that your team needs to rework first.