Gemar S.r.l. - Regulatory references

MDR and IVDR: UDI-DI and Future EU medical device nomenclature

On the EU commission's website you now find the first two guidance documents:
"Draft guidance on basic UDI-DI and changes to UDI-DI" (https://ec.europa.eu/docsroom/documents/28667) and "Future EU medical device nomenclature – Description of requirements" (https://ec.europa.eu/docsroom/documents/28668) published by the MDCG.

The first one offers a bit more information about the UDI system but nothing really new compared to the MDR itself.
Still it is not clear how exactly the UDI system as a whole shall operate. For those of you who don't want to wait with the preparations: I am developing a rather simple transition solution which I'll publish here in the next weeks.
Stay tuned!

The EU’s medical device regulations

The final text of the new European Medical Devices Regulation (MDR) and In Vitro Diagnostic (IVDR) Regulations were published on May 5th 2017 in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May 2017.

The MDR and IVDR timeline

The Regulations entered into force on May 25th, 2017, marking the start of the three years transition period for MDR and five years transition period for IVDR, for manufacturers selling medical devices into Europe.

The MDR replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC); while IVDR replaces the In Vitro Diagnostic Medical Devices Directive 98/79/EC. Manufacturers have the duration of the transition period to update their technical documentation and Quality System processes to meet the new requirements.

Major changes and their impact

This long awaited texts bring an expanded scope of products covered, reclassification according to risks, more scrutiny of technical documentation, more rigorous requirements for clinical evaluation, post-market clinical follow-up, including changes to clinical investigations, mandatory unique device identification (UDI), a better traceability of devices through the supply chain and stricter requirements on post market oversight by the EU Notified Bodies.

Combination products

Article 117 of the MDR 2017/745 directly amends the EU Directive 2001/83/EC concerning medicinal products for human use. This is particularly relevant for manufacturers of devices that administer medicinal products which are single integral, intended exclusively for use in the given combination, which are not reusable, and are therefore governed by Directive 2001/83/EC (see MDR article 1(9)). Hence, the MDR also has a significant impact on pharmaceutical, biotech and biosimilar companies which need a device-constituent part to deliver their medicinal product into the body of the patient. (see also section "Combination products").

How you can prepare?

Manufacturers of currently approved devices are advised to consult us to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.

How we can help?

Gemarmed resources are designated to assist medical devices manufacturers in achieving compliance with the new regulations in the EU and other major markets around the world.

We can offer a range of consultancies services for certification and auditing to manufacturers of medical devices, helping them to manage risks and to protect and promote the health and safety of patients.

GAP ANALYSIS FOR THE NEW EU REGULATIONS FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC DEVICES

Is your company interested to understand the impact of the new EU regulations for medical and in vitro diagnostic devices on your product’s regulatory compliance ?

Our regulatory gap analysis will help you understand the impact of the new regulation on your Products certifications and Quality System and implement solutions.

FDA issues new guidance on Usability and Human Factors Considerations

The US Food and Drug Administration (FDA) has published a new guidance titled "Applying Human Factors and Usability Engineering to Medical Devices", available from here.

Stricter 'Equivalency' Requirements On The Cards For EU Device Clinical Evaluations

A key working group at the European Commission has approved major changes to the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3), including stricter requirements for demonstrating equivalency between a device under evaluation and an approved product.

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FDA issues new guidance on Usability and Human Factors Considerations

Stricter 'Equivalency' Requirements On The Cards For EU Device Clinical Evaluations

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