Confidentiality

All parties in the application of the regulation EU MDR 2017/745 will respect the data and confidentiality obtained during their tasks and without prejudice to provisions in place within other Member States to protect:

• Personal data as per Article 110 Data Protection;
• Commercial information;
• Trade secrets (natural or legal person);
• Intellectual property;
• Property rights, unless;
• Disclosure is in the public interest; and
• The effective implementation of EU MDR 2017/745
  • Inspections;
  • Investigations; and
  • Audits.

Without prejudice to previously mentioned, no information will be communicated by any party without the prior agreement of the originating authority.

None of this will affect the rights of the EU Commission, Member States and notified bodies to include: –

• Exchange of information;
• Dissemination of warnings; and
• Requirement determined by criminal law.

The EU Commission and Member States may, as required, exchange information with third countries where they have bilateral or multilateral agreements in place.