Regulatory Approval.
Testing, approvals and certifications
For medical devices, the conformity assessment procedure under MDR 2017/745 is where you demonstrate that your product is safe and performs as intended. The focus is not on an official “approval” as for medicinal products, but on the CE marking, which you as the manufacturer affix under your own responsibility – often with the involvement of a notified body.
1. Classification and regulatory strategy (the foundation)
The single most important document. You must define precisely what the product does, who uses it, on whom it is used and for which conditions (indications and contraindications).
Based on the intended purpose, you classify the product as class I, IIa, IIb or III in accordance with Annex VIII of the MDR. The class determines the effort involved: for class I (low risk), the manufacturer can usually self-declare; from class IIa onwards, a notified body must be involved and will audit you.
2. Risk management (ISO 14971)
You must demonstrate that the product is safe throughout its entire lifecycle. Risks must be analysed, evaluated and minimised through inherently safe design, protective measures or information for users – in that order.
The medical benefit to the patient must outweigh the remaining residual risks at all times.
3. Technical documentation (the “approval dossier”)
A checklist (Annex I of the MDR) in which you demonstrate for each item how your product meets it – e.g. by reference to standards such as EN 60601-1 for electrical safety.
Evidence from software testing (IEC 62304), biocompatibility (ISO 10993), electrical safety and usability (IEC 62366-1), as well as validation of packaging and sterility.
Drafts of labels and instructions for use (IFU), and assignment of the UDI (unique device identification).
4. Clinical evaluation and clinical evidence
You must use clinical data to demonstrate that the product achieves its clinical performance – by evaluating scientific literature (the MDR sets high hurdles for demonstrating equivalence) or through your own clinical investigations.
For novel products and class III devices, your own clinical studies (investigations in humans) have now become almost the rule under the MDR.
5. The audit procedure & CE certificate
Notified bodies are chronically overloaded – signing a contract early is therefore on the critical path of project management.
In stage 1, the notified body reviews your technical documentation; in stage 2, it audits your quality management system (QMS) on site. Once completed successfully, you receive the CE certificate and issue the declaration of conformity.
On request, we take care of this for you – or we advise and support you in obtaining approval for your medical device.
For an initial conversation, it helps us to know: has the intended purpose of your product already been defined? Is it software (SaMD/DiGA), an active device, or a substance-based or implantable product? And are you already in contact with a notified body?