Medical device compliance follows the product throughout its life cycle. Intended purpose, classification, conformity assessment, technical documentation and market surveillance must match the product actually supplied. Software changes or new advertising claims can alter the regulatory assessment.
What we assess
We connect regulatory requirements with distribution, procurement and liability arrangements. Manufacturers, importers and distributors need access to the information necessary to discharge their own obligations. Safety incidents require coordinated technical assessment, communications and contractual recourse without delaying protective action.
Four practical examples
Illustrative scenarios, not accounts of client matters. The appropriate response depends on the documents, applicable law and procedural position.
An app gains diagnostic functions
A health app starts giving individual diagnostic recommendations. Its classification may change. The intended purpose, functionality and conformity requirements should be reviewed before release; renaming the function does not remove regulatory obligations.
Own-brand distribution
A distributor sells a device under its own name. We assess whether additional manufacturer obligations arise. The supply contract and access to documentation must enable the business to fulfil the duties it actually assumes.
A defect after delivery
Several customers report the same fault. Reports are assessed, affected batches identified and possible information or corrective measures examined. Claims against suppliers are documented in parallel without postponing necessary safety measures.
A hospital tender
A tender demands specific performance characteristics. The supplier must establish that its documentation supports those characteristics. Unclear requirements should be addressed before bidding; unsupported promises may cause both procurement and regulatory difficulties.
Documents that help
Intended-purpose statements, technical and conformity documentation, labels, instructions, supply contracts, complaints and safety communications.
From assessment to the next step
We first distinguish established facts from disputed allegations and identify any step needed to preserve rights. The legal route is then assessed against the commercial objective, available evidence and potential cost. Where technical or foreign-law input is required, responsibilities are coordinated before further work is commissioned. Negotiation, formal proceedings and practical implementation are considered together; a favourable legal position still needs a workable route to the intended result.
Explore all practice areas · Process and fees
Discuss your matter
Tell us the parties involved, your objective and any deadlines. Our main office is in Hanover, Lower Saxony. We advise on German-law matters nationwide and coordinate cross-border work with locally qualified counsel where required.
Send an enquiry — all fields optional · +49 511 3573560
We check conflicts and agree the scope and fees before accepting instructions. An enquiry alone does not create an engagement or preserve a deadline.