The manufacturer inspection under Regulation (EU) 2017/745 refers to the on-site inspection of a medical device manufacturer by a competent authority as part of market surveillance. The legal basis is Articles 93 to 100, which explicitly grant authorities the right to announced and, if necessary, unannounced inspections. This is to be distinguished from the unannounced audit by the Notified Body according to Annex IX Section 3.4, which is not an official measure but part of the surveillance of an issued certificate. Both types of inspections occur concurrently for manufacturers in practice and trigger different legal consequences.
Market Surveillance as a Regulatory Task
According to Article 93(1), competent authorities shall verify the characteristics and performance of products, including a review of documentation and physical checks and laboratory tests on the basis of adequate samples. They shall take into account established principles of risk assessment, vigilance data, and complaints. Paragraph 2 obliges them to draw up annual surveillance plans and to allocate sufficient resources; the Medical Device Coordination Group shall, in accordance with Article 105, establish a European market surveillance programme as a reference framework. According to paragraph 4, authorities shall make available an annual summary of the results of their surveillance activities via the electronic system referred to in Article 100, and according to paragraph 8, the functioning of market surveillance shall be reviewed at least every four years.
Powers of the Authority On-Site
Article 93(3) grants authorities two key powers: they may require economic operators to provide all necessary documentation and information, as well as free product samples, and they may carry out both announced and, if necessary, unannounced inspections in the premises of economic operators, as well as of suppliers and subcontractors, and, if necessary, in the facilities of professional users. According to paragraph 6, the authority shall draw up a report on the inspection visit and communicate the necessary corrective actions; according to paragraph 7, the content shall be communicated to the economic operator concerned, who shall be given the opportunity to comment before the authority enters its conclusions into the electronic system referred to in Article 100. In the case of products presenting an unacceptable risk or falsified products, the authority may, in accordance with paragraph 5, order their seizure, destruction or other rendering inoperable.
Legal Consequences and Measures
If the inspection reveals a substantiated suspicion, the evaluation procedure under Article 94 follows for products presumed to present an unacceptable risk or otherwise be non-compliant. If an unacceptable risk is confirmed, Article 95 applies with withdrawal, recall, or prohibition of making available on the market; in the case of other non-conformity, Article 97 requires conformity to be established within a reasonable period, otherwise, making available and placing on the market may be restricted or prohibited. In parallel, findings affect the certificate: the Notified Body shall, in accordance with Article 56(5), enter all information concerning issued, amended, suspended, reactivated, withdrawn, refused, and restricted certificates into the electronic system referred to in Article 57, where they are publicly accessible. Certificates are valid for a maximum of five years according to Article 56(2) and are renewed for a maximum of five years each after re-assessment.
Preparation and Typical Inspection Focus Areas
Preparation primarily means availability: technical documentation, EU declaration of conformity, certificates, risk management file, post-market documentation, vigilance records, and contracts with suppliers and subcontractors must be available at short notice and in an auditable condition. Frequent focus areas include the consistency of intended purpose, advertising claims, and instructions for use, the up-to-dateness of clinical evaluation and risk analysis, compliance with reporting deadlines, the implementation of announced corrective actions, and the traceability of the supply chain. Since unannounced inspections are permissible, responsibilities, reception processes, and document access should be regulated even in the absence of individual persons. The Notified Body is not involved in regulatory inspections but is informed of relevant findings.
Distinction from Good Clinical Practice Inspection
The GCP inspection does not examine product conformity but rather the proper conduct of a clinical investigation. The subject of examination includes adherence to the clinical investigation plan, consent documentation, source data verification, reporting of events, monitoring, and the integrity of study data; the addressees are the sponsor, investigator site, and contracted service providers. The legal basis for product investigations is Articles 62 to 82 of the Regulation and national implementing provisions, not the market surveillance articles. The legal consequence is typically the suspension or termination of an investigation, the non-usability of data, or a request for additional information, not a sales ban. A manufacturer inspection, however, can only concern study documents insofar as they have become part of the conformity assessment.
Relevance for clinical trials
Study documents become subject to regulatory market surveillance once they are included in the technical documentation. Reports on clinical investigations, data evaluations, and event assessments must therefore remain permanently reconstructable, even after the contract with a service provider has ended. Archiving location, access rights, and retention periods must be contractually regulated and aligned with the deadlines of Article 10(8).
If inconsistencies between clinical data and the intended purpose are found during an inspection, the corrective action usually affects not just one document, but the entire chain of evidence. Full-service CROs like Mediconomics support manufacturers in archiving study documentation in an audit-proof manner and in responding to regulatory requests for clinical data in a structured way.
Frequently Asked Questions (FAQ)
Can an authority appear without prior notice?
Yes. Article 93(3)(b) permits announced and, if necessary, unannounced inspections in the premises of economic operators, as well as of suppliers and subcontractors.
How does the unannounced audit by the Notified Body differ?
It is based on Annex IX Section 3.4, takes place randomly at least once every five years, and serves to monitor the certificate. The audit plan is not communicated to the manufacturer.
Can comments be submitted on findings?
Yes. According to Article 93(7), the authority communicates the content of its report and gives the economic operator the opportunity to comment before the conclusions are entered into the electronic system.
Regulatory References
- Regulation (EU) 2017/745, Article 93(1) to (8)
- Regulation (EU) 2017/745, Articles 94, 95, 97 and 100, and Article 105
- Regulation (EU) 2017/745, Article 56(2) and (5), and Article 57
- Regulation (EU) 2017/745, Annex IX Section 3.4 on unannounced audits
- Regulation (EU) 2017/745, Article 10(8) on retention periods
