The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation
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Record Control for a Regulated World
In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
EU MDR Delays
It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
EU MDR Common Specifications Are Not Common
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).
EU MDR: Importers
The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the...
EU MDR: Distributors
The new European Union regulation for medical devices, EU MDR 2017/745, went into effect only recently and...
Culture and Medical Device Quality
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a...
Post-Market Reporting in the EU
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a lot has...
Lost in Translation: Regulating Medical Devices Around the World
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...
Choosing the Right Path for an FDA Submission
Choosing the correct pathway for submitting an application to get your product approved by the FDA can be...