What Do Medical Device Manufacturers Need to Know?

Device Classification

The first step for all manufacturers will be to determine if their products are defined as a medical device or accessory under the new MDR. After confirming that the MDR applies to your device, it should be carefully classified based on invasiveness, duration of contact, risk and intended use. MDR has four medical device classifications:

• Class I
• Class IIa
• Class IIb
• Class III

Classification is based on the depth of assessment required for a particular medical device, vigilance, post-market surveillance etc. It is important to confirm.

Required Documentation

MDR requires significantly more documentation, including:
• General Safety and Performance Requirements (GSPR) – Annex I
• Quality Management System (QMS) – Article 10
• Technical Documentation - Ek II
• Post-Market Evaluation Plan (Annex II to ER) XIV Annex III
• Authorized Representative, Distributor Agreements – Article 11-14
• Person Responsible for Regulatory Compliance (PRRC) – Article 15

As noted above, specific requirements are determined by device classification.