Compliance
Compliance describes the totality of measures ensuring that a company and its products meet all relevant legal, regulatory, and ethical requirements.
For manufacturers and importers of medical devices and PPE, compliance typically includes:
Product-related compliance:
- MDR conformity (CE marking, technical documentation, clinical evaluation, PMS)
- PPE Regulation conformity (categorisation, type-examination)
- REACH conformity (SVHC notifications, restrictions)
- Food law conformity (Reg. 1935/2004 for food-grade products)
Company-related compliance:
- Quality management system (EN ISO 13485 for medical devices, EN ISO 9001 generally)
- Data protection (GDPR)
- Supply chain due diligence (national laws, EU Corporate Sustainability Due Diligence Directive)
- Anti-corruption and competition law
Compliance vs. conformity:
- Conformity describes the fulfilment of specific technical requirements for a product
- Compliance describes the entire regulatory compliance management of a company
Frequently asked questions
What is the difference between compliance and conformity?
Conformity is a product-specific term: the product meets the requirements of a standard or regulation. Compliance is broader and describes the entire company-wide management of regulatory adherence - including legal, ethical, and internal requirements.
Which laws must medical device manufacturers observe within a compliance framework?
MDR (EU) 2017/745, REACH (EC) 1907/2006, national medical device laws, occupational health law, data protection (GDPR), product liability law, and where applicable biocides regulation, packaging law, and battery regulation.
How is compliance ensured within a company?
Through a compliance management system (CMS): clear responsibilities, training, internal policies, monitoring and audits, whistleblowing systems, and regular review of legal and standards requirements.