What Medical Device Manufacturers Need to Know: Regulations and Compliance

What Medical Device Manufacturers Need to Know?

Regulation of Medical Devices and Regulations

European Union Regulations (MDR and IVDR)

The European Union provides two main regulations for the placing on the market and marketing of medical devices: Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR 2017/746).

MDR (Medical Device Regulation):Adopted in 2017 and entering into force in 2021, the MDR introduces stricter safety and quality requirements for the placing of medical devices on the market.

Scope: Covers both traditional medical devices and software-based medical devices.
Safety and efficacy: The safety and efficacy of products must be demonstrated by detailed clinical data.
Clinical Monitoring and Post-Market Surveillance: Once the product is on the market, it must be continuously monitored and improvements made where necessary.
Risk Management: A risk management process in accordance with ISO 14971 is required.

IVDR (In Vitro Diagnostic Devices Regulation): IVDR introduces similar stringent regulations for in vitro diagnostic devices.

Clinical Performance Data: The accuracy and safety of clinical data for in vitro devices must be demonstrated.
Classification and Notified Body: Devices are assessed by notified bodies according to risk class.

US Regulations (FDA)

In the US, medical devices are regulated by the FDA (Food and Drug Administration). The FDA's rules for medical devices include rigorous regulations to ensure their safety and effectiveness.

510(k) Certification: Devices can be placed on the market by comparing them with devices similar to the FDA.
Premarket Approval (PMA): For high-risk devices, an approval process with more detailed clinical data is required.
Quality System Regulation (QSR): Manufacturers must comply with quality management system (QMS) standards set by the FDA.

Other Regional Regulations

Japan (PMDA): In Japan, medical devices are regulated by the Pharmaceutical and Medical Devices Agency (PMDA).
Canada (Health Canada): In Canada, medical devices are regulated by Health Canada and approval is required for certain classes.
Australia (TGA): In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA).

Device Classification

The first step for all manufacturers will be to determine whether their products are defined as medical devices or accessories under the new MDR. Once you have confirmed that the MDR applies to your device, it should be carefully classified according to invasiveness, duration of contact, risk and intended use. The MDR has four classifications of medical devices.

Class I
Class IIa
Class IIb
Class III

The classification defines the required level of involvement of a Notified Body in the certification process, as well as the depth of assessment, vigilance, post-market surveillance etc. required for a given medical device.

Transition deadlines for currently marketed devices are also based on this classification, so it is important to confirm that this determination has been made correctly.

Mandatory Documents

The MDR requires significantly more documentation, including:

General Safety and Performance Requirements (GSPR) - Annex I
Quality Management System (QMS) - Article 10
Technical Documentation - Annex II
Clinical Evaluation Report (CER) - Annex XIV
Post-Market Surveillance Plan - Annex III
Authorized Representative, Distributor Agreements - Articles 11-14
Person Responsible for Regulatory Compliance (PRRC) - Article 15

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

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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