News

‘Person Responsible for Regulatory Compliance’ (MDR: Article 15)

[acronyms as QP (Qualified Person) and or CO (Compliance Officer) and or LP (Legal Person)] As recognised independent professional service provider we’ve developed (A) QP or CO services for SME organizations or manufacturers;  and (B) QP or CO Training Program. Our ‘Person for Regulatory Compliance’ holds an university degree in…

MDR and IVDR finally published (May 4th, 2017)

European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4th, 2017. The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while…

June 2017: MDR and IVDR significant changes

(May 1, 2017) The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical…

MDR: Changes in the International Clinical Investigations Standard

Many European and IMDRF documents refer to ISO 14155 as a ‘conformity’  standard. So it is an important tool to demonstrate compliance with the EU regulatory requirements. Especially when performing clinical evaluation to demonstrate and provide clinical evidence what is needed and required to support defined medical claim of the…

MDR: Remanufacturing of Singe Use Medical Devices

There are two type of organizations in the EU that remanufacture single use medical devices (SUD) manufactured by ‘original equipment manufacturers’ (OEM): 1)        Hospitals and other healthcare providers called: reprocessors 2)        Commercial re-processors now called:  remanufacturers. Not all EU countries allow ‘remanufacturing’ and up to now remanufactured devices did not fall…

MDR and IVDR challenge: General obligations of the Manufacturer

The definition of Manufacturer means:     ‘the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.’   In other words: the entity that markets the device with its name…
Page 1 of 3

Whitepaper