search.noResults

search.searching

saml.title
dataCollection.invalidEmail
note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
Company insight


Labelling and packaging: MDR and beyond


Esko solutions help companies streamline, and automate labelling and artwork processes across all internal stakeholders and third parties, including CMOs, design agencies, premedia and print companies.


EU and increases patient safety. This article discusses how digital transformation helps medical device companies manage the changes to artwork and labelling due to MDR and other regulatory changes.


M


What does MDR mean for labelling? MDR was to replace MDD in May 2020. However, due to Covid-19, the date of application was extended by the European Commission. MDR compliance will now be required of all companies by May 26, 2021. The extensive changes are patient safety- focused, requiring improvements in device quality, labelling and information. MDR also impacts device packaging, multilanguage booklets and instructions for use (IFUs). Key dates of the foregoing include:


■May 2021, EU MDR replaces EU’s current Medical Device Directive (93/42/EEC)


■May 2022, EC certificates of conformity issued before May 27, 2017 expire


■May 2024, required for all EC certificates issued five years from the issue/renewal date or four years from the MDR date of application (May 27, 2020)


DR compliance is mission critical. It allows medical device companies to sell products in the


■May 2025, MDD-certified devices cannot be sold or distributed.


Does MDR introduce risk? Deloitte estimates over 50% of product recalls are related to labelling or packaging artwork, and human error accounts for 60% of recalls. MDR is requiring reviews and changes across entire product portfolios, which is a significant business challenge. Companies, therefore, need a system and process that adapts to new and changing regulations in order to maintain compliance.


How to streamline the labelling process to avoid errors Complying with MDR and other frequent changes can be overwhelming. Follow these four steps to manage the workload: ■Step 1: determine the labels and artwork impacted by MDR. Identify content required, content owners, update frequency, impact on content layout and in-progress changes that may need to be managed in sequence or bundled.


■Step 2: review current processes and systems. Determine solutions available to manage changes, including required data collection.


■Step 3: streamline the change process. Identify better tools and opportunities for automation. Employ systems that give real-time visibility and automate manual steps.


■Step 4: implement process improvements and supporting tools. Create short, mid and long-term goals for the company’s digital transformation.


Benefits of digital transformation for medical device labelling As regulations evolve and companies continue to improve quality and safety, the rapid pace of change will continue. To meet this increased pace of change, companies are evaluating their digital maturity and exploring the benefits of digital transformation. WebCenter from Esko | Brand Solutions helps companies on that journey with labelling and artwork management. WebCenter increases visibility, improves quality and reduces risk, while also providing the stepping stones to advance to the desired future state. With increased change and a zero-error tolerance, a key component of the journey is automation. This includes simple tasks, such as automated quality checks, file compare and barcode checks. It also includes more complex tasks, such as automated artwork updates using structured content management capabilities. Digital transformation reduces manual touchpoints and risks while streamlining processes. Impact assessments, a traditionally manual-intensive activity, become simple searches with automated solutions. This provides the confidence that no label is missed and consistency is maintained across the product portfolio. MDR is but one of many regulations that will continue to drive the need for change. Having a scalable, connected digital ecosystem sets companies up for success with MDR and beyond. ●


MDR allows medical device companies to sell products in the EU and increases patient safety with required improvements in device quality, labelling, and information.


Medical Device Developments / www.nsmedicaldevices.com www.esko.com/brands 117


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133