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
Most companies in the business of private labeling medical devices for sale in the EU are painfully aware that the new EU Medical Device Regulation (2017/745) is about to make their life a lot harder.
But in case you were not aware, we’ll break the bad news: EU private labeling is having chest pains and is in the ambulance headed for the hospital. The prognosis is uncertain.
A brief recap of the situation
The current Medical Devices Directive (MDD 93/42/EEC) may have permitted a type of own brand labeling (OBL) or private brand labeling (PBL) for placing medical devices on the European market.… » Read more