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Unique Identification of Medical Devices according to the new law

Unique Identification of Medical Devices according to the new law
What awaits us in the near future?

We have already discussed the topic of unique identification of medical devices on our blog. Today we would like to introduce you to the topic of changes in the existing regulations.

UDI regulations have been developed and implemented by the US Food and Drug Administration, the European Commission, and by global regulators. Their main goal is to increase patient safety and improve the quality of healthcare.

According to the initial assumptions, the obligation to place codes on medical labels and packaging was to apply from May 26, 2021 at the earliest (class III). The differences in the date of introducing the regulations depended on the individual classes of the products themselves.

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Own study based on https://gs1pl.org/

On January 6, 2023, the European Commission adopted a proposal to amend the MDR (Medical Devices Regulation) to extend the transitional periods for medical devices. This is extremely important information for manufacturers of medical devices who have been afraid for months that they may not be able to complete MDR-compliant procedures and certification.

The extension of the transitional periods applies to implanted class III and IIb devices until December 31, 2027, and class IIb and IIa devices and class I devices with a measuring function or sterile devices until December 31, 2028. All class I devices according to the MDD (Medical Device Directive), which, according to the MDR, should be classified as a higher class, may be placed on the market, under certain conditions, until December 31, 2028. The extended deadlines apply only to manufacturers who submit a formal application to the notifying body for certification by May 26, 2024, at the latest. An important element of the changes is also the abandonment of the sell-off clause, thanks to which products introduced into circulation before May 26, 2021, will remain on the market longer than until May 2025.

At Prespack, we provide services dedicated to the pharmaceutical industry. On a daily basis, we cooperate with both manufacturers of medicinal products and manufacturers of medical devices. We provide services in the field of contract packaging, repackaging into individual packaging, as well as their serialization and aggregation. We care about the support of our clients, which is why we are happy to share our knowledge about changes-on any modifications to regulations.

ABOUT US

ABOUT US

Prespack offers specialised services of contract packing, repacking and serialisation for EU-originating medicinal products, psychotropic substances and products that require cold chain storage.

 

We provide our services based on a manufacturing authorization for medicinal products and a GMP certificate from the Polish Chief Pharmaceutical Inspector. We offer serialization solutions to marketing authorization holders (MAHs), including those involved in parallel importation (PI MAHs).

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OUR SERVICES

Prespack offers contract services to pharmaceutical companies, including packing, repacking medicinal products into individual packs, and serialisation. We provide our services pursuant to a manufacturing and import authorisation and a GMP certificate. We carry out the following operations as part of our manufacturing process:

SERIALISATION

SERIALISATION

9 February 2019 saw the entry into force in Poland of Commission Delegated Regulation (EU) 2016/161 which requires medicinal product manufacturers to use certain safety features on their products. This posed a serious challenge to pharmaceutical and contract manufacturers who had to bring their manufacturing processes and their technical and computer infrastructure in line with the new regulatory standards.

PRODUCTION OF PACKAGING MATERIALS

PRODUCTION OF PACKAGING MATERIALS

We can offer an added value to marketing authorisation holders (MAHs), including those involved in parallel importation (PI MAHs). Our in-house printing facilities are an additional advantage in that we can offer end-to-end production services for packaging materials, including internal logistics and subsequent customising processes.

QUALITY POLICY

QUALITY POLICY

All our manufacturing operations are carried out based on the current GMP guidelines. With our state-of-the-art technology and the Quality Assurance System, we can guarantee product safety and competitive service. We commit all our efforts and resources to make sure that our clients’ final products are as expected by them and fully compatible with Directive 2011/62/EU.

CAREER

CAREER

We are a fast growing business and we are open to new challenges. This makes us the perfect place to build and develop your career at. Choose a job that is full of challenges and will let you step up your skills and qualifications. We create quality in the workplace and we carry out our work with enthusiasm and commitment.

NEWS

Unique Identification of Medical Devices according to the new law

Unique Identification of Medical Devices according to the new law


Unique Identification of Medical Devices according to the new law What awaits…

Aggregation in the pharmaceutical industry.

Aggregation in the pharmaceutical industry.


The next step after serialization.  Globalization is a phenomenon that strongly affects  development…

CONTACT

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Prespack sp. z o.o. 
Sadowa 38 
60-185 Skórzewo

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Phone: +48 61 839 24 75
Office: +48 606 841 900
Customer service: +48 517 344 350
Warehouse: +48 603 292 499+48 604 802 929

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NIP: 7812016420
REGON: 387877393
KRS: 0000877047
E-mail: office@prespack.pl

Wysokość kapitału zakładowego: 360 000,00 zł, Sąd Rejonowy Poznań – Nowe Miasto i Wilda w Poznaniu, VIII Wydział Gospodarczy Krajowego Rejestru Sądowego