MDD to MDR – key changes in regulations:

Scope expansion of regulated devices – the new regulation clarifies and expands the scope of regulated MDs to include – aesthetic devices with a non-medical purpose yet are akin to MDs in terms of function and risk profile, specific rules for devices incorporating nano-materials and devices intended to be orally ingested and medical software. There is also an expansion of rule 17 to include devices manufactured utilizing non-viable tissues/cells of human origin.

Stringent clinical evidence and documentation, which obligates high-risk device manufacturers to make a summary of safety and performance publicly available, with key elements of the supporting clinical data.

Increased focus on identification and traceability – proposed by IVD Regulation, mandates medical device manufacturers to fit their devices with a Unique Device Identification (UDI). The proposed regulation provides detailed information that must be accessed through the UDI.

Increased Notified Body (NB) authority, involvement and unannounced factory audits/inspections – NBs will have a right/ duty to carry out unannounced factory audits/inspections and conduct physical/ laboratory tests on devices. The proposal also demands rotation of the notified body’s personnel involved in the assessment of MDs at appropriate intervals as well as a ‘scrutiny’ procedure of the NB’s preliminary assessment report for implantable MDs classified as class III by Member State Authorities’ Committee, prior to the granting of the certification.

More rigorous vigilance and market surveillance – the EU Commission proposes to set up and manage an electronic system to collate and process documentation by manufacturers on critical incidents, field safety – corrective actions, notices and routine summary reports.

A minimum of one person responsible for regulatory compliance, who possesses in-depth knowledge in the field of MDs.

How to take the next step towards EU MDR compliance?

Complex R&D process combined with requirement to implement the news changes, will make the transition from MDD to MDR a potentially complicated and time-consuming process for most economic operators – MD manufacturers, importers & distributors.

With a lot to be achieved between now and 2020, the MD manufacturers are encouraged to stay current on the progress of the MDR in tandem with a designated Notified Body while keeping in mind expected delays in the review & certification process by such bodies. Manufacturers of currently certified devices are advised to consult their respective Notified Body to evaluate potential compliance issues and develop a plan to address them promptly.

MD manufacturers, importers and distributors will be subject to compliance requirements by designated NB. Krypt, as a leading SAP GTS and TM partner can help small to large Importers & Distributors evaluate ― compliance gaps, address inefficiencies, improve cost-efficiency. Krypt can provide solutions through system automation to:

• Automate existing manual processes,
• Harmonize & align trade and supply chain regulations, classification, coding & labelling of Medical Devices,
• Increase process visibility, product traceability & identity through UDI,
• Provide documentation through linking of data with detailed UDI
• Flag/block shipments that might not be conforming for lack of registration or other reasons.