MEDIMARK EUROPE

PPWR Impact on Medical devices and IVDs products (Packaging and Packaging Waste Regulation 2025/40)

Rene Clement — 2025-09-30T10:30:18Z

What are the specific exemptions for medical device and IVD plastic packaging?

The Packaging and Packaging Waste Regulation (PPWR) recognizes the unique functional, safety, and hygiene requirements of medical device and in vitro diagnostic (IVD) packaging and provides specific exemptions from key sustainability requirements.

These exemptions primarily apply to contact-sensitive plastic packaging for medical devices and IVDs.

1. Exemptions from Recyclability Requirements (Article 6)
The general rule that all packaging placed on the market must be recyclable does not apply to the following categories of medical and diagnostic packaging:
• Contact-sensitive packaging of medical devices covered by Regulation (EU) 2017/745 (MDR).
• Contact-sensitive packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 (IVDR).
• Immediate packaging (which is in direct contact with the medicinal product) and outer packaging of medicinal products (for human or veterinary use) in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product.
The PPWR states that these exemptions for medical devices and IVDs apply until at least January 1, 2035. By this date, the European Commission is required to review these exceptions, taking into account the evolution of sorting and recycling technologies and practical experience, to assess the appropriateness of their continuation.

2. Exemptions from Minimum Recycled Content (Article 7)
The mandatory minimum percentages of recycled content required for plastic packaging placed on the market by 2030 and 2040 do not apply to the following:
• Contact-sensitive plastic packaging of medical devices (including devices exclusively destined for research use and investigational devices) covered by Regulation (EU) 2017/745.
• Contact-sensitive plastic packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746.
• Immediate packaging and outer packaging of medicinal products (for human or veterinary use) in cases where the packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product.
• Packaging of supplies, components, and immediate packaging components for the manufacturing of medicinal products (human and veterinary) where such packaging is needed to be in line with the quality standards of the medicinal product.
These minimum recycled content requirements are indefinitely suspended for these sensitive applications, but the Commission must assess the need for derogations or revisions of this list by January 1, 2028. This assessment will focus on the availability of suitable recycling technologies, especially concerning contact-sensitive plastic packaging.

3. Exemptions from Labeling Requirements (Article 12)
The requirements for standardized labeling (material composition, QR codes, etc.) do not apply to immediate and outer packaging as defined in the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746), provided that either of the following conditions is met:

– There is no space on the packaging due to other labeling requirements mandated by those Union legal acts.
– The labeling of the packaging could jeopardize the safe use of medicinal products for human use or veterinary medicinal products.

4. Other Related Provisions
• Reuse Targets: Reuse and refill targets generally do not apply to healthcare packaging, recognizing that certain packaging cannot be reused for health and safety reasons.
• Extended Producer Responsibility (EPR): Despite the exemptions from recyclability and recycled content, healthcare packaging is not exempt from the obligation to pay Extended Producer Responsibility (EPR) fees. These financial contributions will be eco-modulated based on recyclability performance grades, meaning packaging that is harder to recycle may incur higher fees.
• Substances of Concern: The PPWR's requirement to minimize substances of concern, including the longstanding limit of 100 mg/kg for the sum of lead, cadmium, mercury, and hexavalent chromium, applies unless superseded by specific chemical or food safety restrictions.
• Contact-Sensitive Definition: Contact-sensitive packaging refers to packaging intended for products covered by regulations including the MDR (EU 2017/745) and the IVDR (EU 2017/746).

Welcome

Rene Clement — 2025-09-30T09:44:00Z

PPWR Impact on Medical devices and IVDs products (Packaging and Packaging Waste Regulation 2025/40) - See section Last News

UDI/Device registration

Rene Clement — 2024-12-03T10:54:55Z

My company already has an assigned SRN, how do I register the devices in Eudamed?

The person submitting the SRN application obtains the LAA profile. To view your profile, simply click on your name on your account home page.

The LAA is the Local Actor Administrator and is responsible for managing the Actor data.

To be able to register devices you must have UDI/Device “Confirmer” profile. By default, after Actor registration, your profile in the UDI/Device section is “Viewer”. To upgrade to “Confirmer” status, a second LAA has to be registered. A person needs to submit user access request with LAA profile and a current LAA needs to approve it.

Once there are two LAA, you can switch your profile from “Viewer” to “Confirmer”. Click on « Request for change », complete all the fields and submit. The second LAA needs to approve your request. Once approved, you will be able to create and edit records in the UDI/Devices module.

REFERENCE DOCUMENTS FOR VIGILANCE PROCEDURE

Rene Clement — 2024-12-02T12:14:27Z

Is MEDDEV 2.12/1 rev. 8 still valid for Vigilance procedures?
If not, what are the reference documents?

The MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC (MDD), Directive 90/385/EEC (AIMDD)) and Directive 98/79/EC (IVDD)). It is not aligned with the requirements of the Regulations and is considered. obsolete

You shall update your Vigilance Procedures with the following documents:

– 2024-01-15 MDCG 2024-1 Guidance on the vigilance system for CE-marked devices & DSVG 00 Template – January 2024

– 2024-11-01 MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the MDR & IVDR Regulations.

And eventually:

– MDCG 2021-1_MDR guidance-administrative-practices_en until EUDAMED is fully
functional

– MDCG_2022-12_ IVDR guidance-administrative practice until EUDAMED is fully functional

ISO 13485 audit – MDR & IVDR

Rene Clement — 2024-12-02T11:44:00Z

Are there any specific items in MDR / IVDR with regards to QMS that you need to know to succeed in the audit that is over and over ISO 13485:2016?

In fact, you need to integrate into your QMS certain processes such as clinical evaluation, risk management, post-market surveillance, and assignment of unique device identification which are not included into the ISO 13485-2016 requirements.

Since most manufacturers have already procedures for these processes, they have to integrated into their QMS to be compliant.

Manufacturers need to have on hand for the Audit the Amendment A11 to ISO 13485:2016 (EN ISO 13485:2016/A11:2021 - Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)

It includes Annexes ZA and ZB that link the standard to the requirements of Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro diagnostic medical devices).
The Annexes ZA and ZB compares ISO 13485 to the requirements of Regulation (EU) 2017/745 & 2017/746 stated in Article 10 (General obligations of the manufacturers), in Annex IX and XI (Quality Management System Requirements in the conformity Assessment Annexes).

There are two important notes in annex ZA and ZB

Risks must be reduced as much as possible, but the idea of the regulation is more to control the risks according to the state of the art, not more.

The manufacturer's policy for determining acceptable risk must be in compliance with General Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the MDR and 1, 2, 3, 4, 5, 8, 9, 10, 11, 13, 15, 16,17, 18 and 19 of the IVDR.

In Vitro Diagnostic Medical Devices

MME, Rene Clement — 2024-11-27T23:00:00Z

Services provided by MediMark-Europe, ISO 9001-2015 certified for its EAR activities:

Operational assistance in designing multilingual labels in compliance with the IVDR 2017/746/EU requirements;

Electronic File templates submitted for building Technical Documentation;

Reviews technical documentations and maintains a copy at disposal of competent authorities;

Comply with the registration obligations for EAR laid down in the IVDR 2017/746/EU;

Consulting for initial compliance and maintenance of compliance in regards to the above activities;

Permanent hot line for advises about Regulatory Affairs in Europe;

Supply of European regulatory documents on e-mail request and in MediMark Library Resources.

Assessment Report for incident classification and reportability;

Upon review and approval by the Manufacturer, send Initial and final incident reporting to the relevant National Competent Authorities and answers to their follow-up questions;

Upon review and approval by the Manufacturer, send Initial, Follow-up and Final FSCA reports to the relevant National Competent Authorities and answers to their follow-up questions;

FEES:

The fees are based on a fixed annual basic Administrative fee and annual fees in relation with the number of product designations handled. Fees for Vigilance issues (Incident Reporting, Field corrective action, recall etc . . ) are invoiced separately.

Medical Devices (MD)

MME, Rene Clement — 2024-11-27T23:00:00Z

ANNUAL ADMINISTRATIVE FEES PER PRODUCT FAMILY & VIGILANCE FEES

Fee structure is composed of:

• a flat annual administrative fee based on classification of devices and the number of product families, payable annually or six-month payment schedule and,

• vigilance fees fixed in relation with the severity of the Incident and FSCA/recalls.

Flat administrative includes:

Use of MediMark® Europe's name and address for CE Mark labelling;

Operational assistance in designing multilingual labels in compliance with the MDR 2017/745/EU
requirements;

Electronic File templates submitted for building Technical Files;

Reviews technical file and maintains a copy of the full Technical File at disposal of competent authorities;

Comply with the EAR registration obligations laid down in the MDR 2017/745/EU;
Assistance for Manufacturer registration (SRN) into EUDAMED

Consulting for initial compliance and maintenance of compliance in regards to the above activities;
Permanent hot line for advises about Regulatory Affairs in Europe;

Supply of European regulatory documents on e-mail request and in MediMark Resource Library

Key addresses for basic information

Rene Clement — 2024-11-14T09:00:00Z

MediMark Europe has selected very helpful links for finding easily the updated official European regulatory documents and to feed some other regulatory needs.

EU Commission Overview :
https://ec.europa.eu/growth/sectors/medical-devices_en

EU Commission New Regulations :
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

EU Commission Guidances :
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#Guidance

MDCG Guidances MDR & IVDR
https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

EU Commission UDI Helpdesk made by the EU Commission
https://webgate.ec.europa.eu/udi-helpdesk/en/welcome-to-eu-udi-helpdesk.html

European information system for Medical Devices (EUDAMED)
https://webgate.ec.europa.eu/eudamed

CAMD Competent authorities for Medical Devices – Information new MDR
https://www.camd-europe.eu/

Harmonized Standards for MD:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Harmonized Standards for AIMD :
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices/index_en.htm

Harmonized Standards for IVD :
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm

List of contact points (Vigilance & others) within the EU national competent authorities :
https://ec.europa.eu/growth/sectors/medical-devices/contacts_en

CAMD Competent authorities for Medical Devices – Information MDR & IVDR
https://www.camd-europe.eu/

Recommendations \"NB-MED\" issued by the European association of Notified Bodies for Medical Devices (including IVD's).:
http://www.team-nb.org/

Official journal of the European Communities :
http://eur-lex.europa.eu/homepage.html?locale=en

ANSM: French Drug and Medical Agency :
http://ansm.sante.fr/

MHRA Competent Authority for United Kingdom:
http://www.mhra.gov.uk/index.htm

British Standards Online for all publications from BSI Standards:
https://www.bsigroup.com/en-GB/products-and-services/standards/

MedTech Europe - EDMA & EUCOMED - EU Manufacturers Association:
http://www.medtecheurope.org/

2024-11-08 EU Parliament adopted a resolution for an Urgent need to revise the medical devices regulations

Rene Clement — 2024-11-08T11:36:48Z

2024-10-23] For weeks, pressure has been mounting, particularly among the professional associations of medical device manufacturers, to ask the European Commission to take urgent measures to revise the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). German MEP (and doctor) Peter Liese, with the active contribution of Dutch lawyer Erik Vollebregt, has launched an initiative to convince the European authorities to adopt substantive measures to correct the inherent defects of both regulations, and not to postpone the deadlines related to the regulations once again, as was the case before. These very concrete (and common sense) measures are essentially aimed at reducing the risks of device shortages, supporting innovation, making EUDAMED fully operational, and introducing more visibility and harmonization in certification and market access procedures.

On the basis of this initiative, the European Parliament finally adopted on 23 October 2024 a resolution entitled “Urgent need to revise the medical devices regulation”, in which it urges the European Commission to implement the recommended measures before the end of the first quarter of 2025. During the debate, MEPs asked the Commission to propose measures within 100 days of the Commission's next term.
What is surprising is that these proposals include measures that had already been proposed by the European association MedTech Europe, almost 2 years ago, in an infographic of 8 November 2022 .

However, there is no point in celebrating too soon: when the topic was debated in Parliament on 9 October 2024, European Commission Vice-President Věra Jourová concluded the discussion by stating that it was imperative to avoid taking any initiative in a hurry. It is necessary, he added, to be based on data and to involve all stakeholders. A targeted assessment is underway, and it is important to take into account all sources of information and points of view in order to carry out a comprehensive assessment.
One could argue that numerous surveys show that shortages of medical devices are already a reality, that the explosion in costs and delays in obtaining EU certificates according to the regulations is severely penalizing SMEs and micro-enterprises in the sector, that innovation within the EU is in decline and that manufacturers, in order to survive, are turning to regions where market access is much faster than in Europe. But these investigations mainly come from professional unions in the field (see for example the SNITEM study presented on 5 February 2024): the Commission certainly prefers to rely on its own investigations (currently underway), which are considered more impartial.

The network of national competent authorities responsible for medicines and medical devices, called "Heads of Medicine and Medical Devices Agencies" or "HMA" (of which the ANSM in France is a part), adopted a position similar to that of the Vice-President of the European Commission in a press release published on 18 October 2024: the HMA expresses its deep concern at the request made to the Commission to present a proposal within such a short period of time (100 days). The HMA indicates that the situation should not be made even more confusing by legislative measures taken in haste, without prior in-depth examination or appropriate impact assessment. The Biomed Alliance in Europe, representing 35 medical and research companies, took a position on 10 October 2024 in a statement in English entitled “Hasty plans to amend medical device regulations risk further neglecting the needs of patients who depend on medical technologies”. The organization recommends conducting a detailed review of each regulation, based on a scientific approach, and taking targeted measures separately in the short term, particularly for orphan and pediatric devices.

In short, it seems highly unlikely that substantive and general measures can be implemented by the end of March 2025, as recommended by the European Parliament. Changes to the two medical device regulations will probably be adopted, but probably much later. On the other hand, highly targeted provisions could see the light of day in the shorter term.

October 2024: European Commission published Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860

Rene Clement — 2024-10-31T11:00:59Z

From 10 January 2025, Manufacturer should inform the competent authority of the Member State where it or its authorized representative is established, the economic operators (EO) and health institutions to whom the manufacturer directly supplies the device, of interruptions or discontinuations of the supply of a device when it could result in serious harm or a risk of serious harm to patients or public health. The information shall be provided at a minimum 6 months in advance using a ‘Manufacturer Information Form' (not yet available)

The main reasons of interruptions or discontinuations of the supply of a device are:

• A loss of compliance with a condition in Article 120 of the MDR / Article 110 of the IVDR to place a legacy device on the market
• Delay in certification of the type of device (including a corresponding substitute) against the requirements of the MDR or IVDR
• Suspended or withdrawn certificate
• Decision by the manufacturer of the type of device to not pursue certification in compliance with the MDR/IVDR and to stop marketing of the device (discontinuation)