European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14

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 […]

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Regulating Medical Device Virtual Manufacturers: What OBL and PBL Private Labelers Need to Know About the EU MDR

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) […]

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Did You Get What You Paid For? Evaluating Products Purchased from Medical Device Suppliers and Contractors

This is the final installment of a 4-part blog series on supplier management. Read part 1 here. We’ve combined all four posts into one easy-to-read PDF. Download it here. When purchased products arrive at your facility, you need to confirm that they meet the requirements established in your quality agreement. What’s the best way to go about that? First, consider the risk associated with the purchased product and then examine any actions the supplier has already taken to verify compliance. Choosing […]

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On-Site Audit. Desktop Review. Supplier Self-Evaluation. How Should I Evaluate My Medical Device Suppliers?

This is the third installment of a 4-part blog series on supplier management. Read part 1 here. We’ve combined all four posts into one easy-to-read PDF. Download it here. Spotty quality. Price increases. Poor reliability. There are myriad reasons why medical device suppliers go from “approved” to “disqualified” on your Approved Supplier List. Regardless of how many suppliers you have, it’s important (and required) that you monitor their performance and conduct regular evaluations. This will allow you to make informed business […]

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