New Regulations on Medical Device Directive MDR

The Medical Device Regulation (MDR) is a new regulation that replaces the Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Device (AIMD) Directive 90/385/EEC. It is applicable to all medical device manufacturers who intend to include their products in the European Union (EU).

It is applicable to all medical device manufacturers who intend to include their products in the European Union (EU). We can provide product MDR directive certification services (NB certification), and related product CE certification can be obtained by consulting us!

Medical Device Regulation MDR-LRQA

New EU MDR requirements and key changes:

MDR is significantly different from the upcoming MD directive (93/42/EEC), which was first introduced in 1993, and includes a series of new requirements and major changes, including:

1. Broader scope of regulated devices This regulation clarifies and expands the scope of regulated MD devices, including aesthetic devices with non medical purposes, but similar in function and risk to medical devices, specific rules for devices incorporating nanomaterials, and devices intended for ingestion or inhalation and medical software. The extension of Rule 17 also includes devices manufactured using non living tissues or human derived cells.

2. New classification rules for active implantable devices that expand the scope to include products with aesthetic or non-medical purposes but similar in function and risk to medical devices, oral products utilizing nanomaterials, and devices with qualification assessment requirements.

3. More rigorous clinical evidence and documentation, including the obligation of high-risk device manufacturers to publicly provide safety and performance summaries, as well as key elements of supportive clinical data.

More emphasis on identification and traceability - According to the proposed IVD regulations, medical device manufacturers must ensure that their devices comply with Unique Device Identification (UDI). The proposed regulations provide detailed information that must be obtained through UDI.

4. Increase the power of announcement agencies to participate in and conduct unannounced factory audits/inspections. NBS has the right and obligation to conduct surprise inspections and conduct physical or laboratory tests on equipment. The proposal also requires the rotation of personnel from designated institutions participating in the evaluation of medical doctorates at appropriate time intervals, as well as the "detailed review" procedure for preliminary evaluation reports of designated institutions designated by the competent authorities of member states as Class I1 implantable medical devices. Grant certification.

5. Stricter vigilance and market supervision. The European Commission recommends the establishment and management of electronic systems for manufacturers to organize and handle serious accidents, on-site safety corrective measures, on-site safety notifications, and regular summary reports.

At least one person responsible for regulatory compliance has professional knowledge in the field of medical devices.