What is the EU Person Responsible for Regulatory Compliance (PRRC) role in the EU MDR?
What is the EU Person Responsible for Regulatory Compliance (PRRC) role in the EU MDR? Compliance with European regulations has become progressively more complex, especially with the introduction of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). European regulators want to make sure companies always have a qualified regulatory expert at […]
Read More
EU IVDR Compliance for In-House Lab Developed IVD Tests
EU IVDR Compliance for In-House Lab Developed IVD Tests When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests have had it pretty good├óΓé¼┬ªalong with most other IVD manufacturers. While the EU├é┬áIn Vitro├é┬áDiagnostic Directive (IVDD 98/79/EC) exempted makers of so-called in-house tests (aka LDT), the new├é┬áIn Vitro├é┬áDiagnostic Regulation does not carve out […]
Read More
The EU IVDR: An Overview of Regulatory Requirements in 2017/746
The EU IVDR: An Overview of Regulatory Requirements in 2017/746 Since the introduction of the├é┬áIn Vitro├é┬áDiagnostic Directive (IVDD 98/79/EC) 20+ years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. That├óΓé¼Γäós because under IVDD 98/79/EC, about 80-90% of finished devices are not subject to […]
Read More
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe├óΓé¼Γäós new In Vitro Diagnostic Regulation (IVDR 2017/746) will impose strict new requirements on many IVD manufacturers […]
Read More
Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now
Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now The new European├é┬áIn Vitro├é┬áDiagnostic Regulation (IVDR 2017/746) went into effect on May 26, 2022. At that time, 80-90% of all IVD manufacturers will have been reclassified to Class B or higher and therefore required an audit by a European Notified Body approved to […]
Read More
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
Class 1 Medical Device Manufacturers Must Meet These EU MDR Requirements Right Now You may have read that the transition deadlines for the European Medical Device Regulation (2017/745 MDR) has been extended to 2028. That├óΓé¼Γäós true. But what many Class 1 device manufacturers do not realize is that they still need to comply with certain […]
Read More
