If you have been looking at your upcoming device certification renewal dates or pondering a new product introduction, you may be perplexed about the timelines for MDR implementation and how to proceed. You are not alone.
Following are a few common questions our EU MDR consultants are hearing from our customers related to grandfathered devices, design changes, up-classification, and what happens to MDD-certified devices in distribution after 2020.… » Read more
The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year.
1 – Internal audits and gap assessments
The new European medical device and in vitro diagnostic regulations (EU MDR and EU IVDR, respectively) will certainly demand more attention from regulatory professionals in 2019.… » Read more
Compliance with European regulations has become progressively more complex, especially with the recent publication of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). With the new regulations, European regulators want to make sure companies always have a qualified regulatory expert on staff or at their disposal to ensure the company is meeting EU requirements.
You may have heard about a new role called the Person Responsible for Regulatory Compliance as defined in the new EU MDR and IVDR. Article 15 of the European MDR and IVDR mandate the appointment of this person.… » Read more
When the European Medical Device Regulation (2017/745) was published in 2017, few medical device importers and distributors were aware of the new requirements that would be placed on them. Most of the compliance focus under the Medical Devices Directive (MDD 93/42/EEC) was squarely centered on manufacturers. In fact, the word “importer” only appears three times in the entire MDD and the word “distributor” does not appear at all! The EU MDR, however, elevates the importance of all economic operators, and “importer” and “distributor” appear dozens of times throughout the regulation.… » Read more