Welcome to our blog

Unique Device Identification (UDI) systems are arising worldwide, and understanding similarities and differences between them is key to be able to meet the requirements for each specific country or region.

What is more important than language and translation to connect cultures?

It is Child’s Safety Week from June 7 – June 13 2021 and we would like to raise awareness for this very important topic as well. This year’s slogan of the event “Share because you care” is why we would like to share our knowledge with you.

In our last article, we discussed the confusing situation regarding remote audits and the strategies that manufacturers can follow in order to qualify for this type of inspection under the MDR. In this article we focus on analysing Notified Bodies’ experience while conducting remote audits under the MDD and giving you practical advice for successfully going through it and try to devise the future of remote audits.

Learn about remote audits under the MDD and MDR, a temporary alternative to in-person audits during the COVID-19 pandemic.

In honor of January 4th, the World Braille Day, this article raises awareness of the importance of considering all aspects when designing packaging in the pharma industry.

The European Commission will make available the actor registration module to Member States and economic operators from December 1st, 2020. What do you need to know to be ready for it?

Considerations on inclusion of standards in your technical documentation (acc. to MDR, Annex II) / your documentation for the notified body opinion (acc. to MDR, Article 117) – the importance of clarity.

The packaging of a product serves many different purposes: Inform the customer about the content, protect the product during transport, storage and handling processes, convince customers to buy it and also keep the product safe from tampering.

Continuing with the topic of our last article, we analyze the requirements to consider in Part 2 of Article 117 of the MDR in the checklist attached.

Are you planning to gain a Notified Body Opinion for your device? Make sure you are taking everything into account with our checklist.

Substantial or significant (used interchangeably) changes are a key element in lifecycle management of medical devices or device parts of (single) integral products.

Few requirements in of the EU MDR [Regulation (EU) 745/2017] are as impactful as those related to single integral products combining a medicinal product part and a device part. For those products described in the second paragraph of Article 1(9) in particular, such as syringes and non-usable auto-injectors, the impact of the EU MDR is indeed massive. As the use of such integral products has become widespread for medicinal products, the new requirements pose a double challenge for Pharmaceutical companies: by May 26 2020, MAHs need to comply with the new General Safety and Performance Requirements of Annex I, and in addition they must get such products “cleared” by notified bodies for future applications to EMA.

The EU Medical Device Regulation (MDR) introduces, as part of Annex I General Safety and Performance Requirements, new material and substance requirements for medical devices and device parts of single integral products. The aim of these new requirements is reducing as far as possible the risk posed by substances or particles from materials, degradation products and processing residues that may be release from the device.