INSIGHTS AND COMPLIANCE

As Technology constantly changes, so do the standards and regulations.

Medical Device Regulation

(MDR 2017/745)
Extensive reform to the rules that govern the European sector represent the most disruptive changes to the industry in recent history. Since the MDR has replaced the current directive, in general, companies have three years to comply. These regulations will affect almost all products in the medical device spectrum. Our experts have the knowledge and understanding to help your organisation navigate safely through the changes.

KEY CHANGES

Wider Product Scope

Manufacturers will need to generate and provide more rigorous clinical data for class III and implantable medical devices where existing data is considered insufficient.

Clinical Data

Manufacturers will need to generate and provide more rigorous clinical data for class III and implantable medical devices where existing data is considered insufficient.

Grandfathering

There is no grandfathering of products. The MDR requires that all currently approved devices must be re-certified in accordance with the new requirements.

Medical Device Responsible Person

Device manufacturers will be required to identify and appoint at least one person who is ultimately responsible for ensuring compliance to the MDR.

Traceability

The MDR requires the use of a unique device identification (UDI) mechanism. Manufacturers will be required to report medical device related incidents, injuries or deaths.

Rigorous post-market oversight

The MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits of manufacturers, together with product sample checks and testing.

Specifications

The MDR legislates that the common specifications (CS) are to be defined and published by the EU Commission or expert panels. These common specifications shall exist in parallel to the harmonized standards for medical devices and the state of the art.

The deadlines are clear and so should your assessment and strategy.

Medical Device companies operating in Europe must begin to prepare for the transition to the new Medical Device Regulation, as there are many varying factors to consider when planning an effective and efficient transition strategy.

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CQV TEAM

Focused on providing consulting services and solutions for the medical device, pharmaceutical and bio-pharmaceutical industries across all sectors, Engineering, Commissioning, Validation, Quality , Remediation and Compliance.

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