MPPE Position on Information Requests on Plastic Materials for the Purpose of Compliance with MDR (2017/745) and IVDR (2017/746)
11 May 2020
Background
Plastic materials and modern medical devices make a perfect fit. Plastics Medical Devices offer increasingly integrated health care services and solutions to improve hospitals, physicians and health care systems efficiencies.
Since the entry into force of new regulations such as REACH, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR)as well as listing of new identified CMR substances in the CLP Regulation, the demand for information on material compositions for the purpose of compliance has increased rapidly.
In the European Union (EU), the European Parliament adopted two new regulations that significantly tighten the requirements for medical devices, including in IVDs. The MDR EU2017/745 and the IVDR EU2017/746 will go into effect in 2021 and 2022, respectively, with full implementation dates that stretch to 2025 depend on class of device and will apply to all companies placing medical devices (MDs) or in vitro diagnostic devices (IVDs) on the EU market (see infographic).
MDR and IVDR introduce new requirements for OEM / brand-owners related to plastics materials used in manufacturing of medical devices. The subject is highly complex, in some cases lacking clear definitions, and successful implementation will require sharing of knowledge and co-operation up and down the supply chain.
MedPharmPlast Europe (MPPE) members have a unique position being a cross-industry body with broad and deep collective knowledge specific to plastics use in the Healthcare industry. Therefore, this document is intended to pro-actively inform stakeholders, who have requests for information on the plastic materials used, providing them with better understanding on what types of response can be expected.
Overview of simplified supply-chain for plastic parts
Supply-chain of plastic parts is not necessarily simple and involves different industries, sometimes with complex material flows. The following picture shows an overview of simplified supply-chain for plastic parts used in medical devices, in-vitro diagnostics and pharmaceutical packaging.
The simplified version hides certain complexity that has an impact on information flow for regulatory purposes, such as:
• Multiple suppliers
• A single plastic product may contain multiple substances e.g. What appears as 1 ‘color’ formula can contain 5 substances. Different suppliers for what appears to be the same product, may have different substances inside.
Specific requirements on plastic materials used in MDs and IVDs
For all MDs governed by the MDR, the ‘Brand-owner’ must determine if their final device:
1) contains >0.1% weight by weight (w/w) of:
• Carcinogenic, Mutagenic or Reproductive toxic (CMR) substances (Category 1A or 1B) as identified under CLP Regulation (1272/2008)
• Endocrine Disrupting (ED)substances for which there is scientific evidence of probable serious effects to human health as identified through article 59 of the REACH Regulation or Biocidal Product Regulation.
2) contains Nanomaterials, materials of biological origin, latex and phthalates
For all IVDs governed by the IVDR, the ‘Brand-owner’ must determine if their final device contains:
• CMR substances as identified under CLP Regulation (1272/2008);
• ED substances for which there is scientific evidence of probable serious effects to human health as identified through article 59 of the REACH Regulation;
• Biological substances.
Carcinogenicity, mutagenicity, repro-toxicity and endocrine-disrupting properties are valid reasons for inclusion of a substance in the Candidate List of the REACH regulation. The Candidate List currently identifies 205 Substances of Very High Concern (‘SVHC’), but is updated every 6 months. Also, the Candidate List does not perfectly match with the CLP list. All CMR substances identified under CLP Regulation are not identified as SVHC (for example 1,3-butadiene, CAS Nr 106-99-0, Carcinogenic and mutagenic substance of category 1A and 1B, respectively, as per CLP Regulation.)
This will require stakeholders to have skilled product stewardship professionals and also raises the question for the MD and IVD producer and their supply chain how to keep up-to-date?
MPPE members activities to support MDR /IVDR
MPPE members benefit from a shared expertise of healthcare market specialists coming from different parts of the supply chain, including polymers, compounds / masterbatch, converters / contract manufacturers, test laboratories and medical device and pharmaceutical companies. MPPE members will:
• Bring knowledge of your market, the regulations and how they impact plastics
• Act with openness
• Attempt to answer your questions based on best information, and if this attempt fails, … substantiate why.
• Support you with your documentation and your regulatory dossier submission
• Provide available information regarding substances listed in various regulations including MDR
• Provide specific declarations based on testing where available, for products defined as ‘medical’, ‘pharma’ or ‘healthcare’.
• Pre-notify customers of change for designated Healthcare products
• Implement/integrate change control and risk management in our raw materials processes
However, it should also be understood that:
• The supply chain of polymers, pigments and additives that are used, does not and cannot test for all the potential substances. Therefore, suppliers of these materials usually give ‘Not Intentionally Added Substance’ (NIAS) statements.
• Residuals and impurities in plastics parts, polymer compounds and masterbatches are possibly created and/ or modified by downstream processes: e.g. by dilution into another polymer, by heat and pressure in molding and by terminal sterilization. Therefore, the precise composition can only be determined on the final MD / IVD.
What can be provided for Healthcare Designated Products
Composition disclosure: Chemical Abstract Substance Number (CAS Nr) and percentage to the end-device producer responsible for registration. Signature of a confidentiality agreement is usually required.
2) Information on certain substances regulated in the MDR or IVDR:
a) CMR/ED substances listed that are also SVHC (Substances of Very High Concern) defined in REACH EC1907/2006 Annex XIV
b) CMR/ED substances that are not SVHC but are intentionally added
c) For all other substances not fitting a) or b); a ‘Not Intentionally Added Substance’ (NIAS) statement
d) Declaration of content of ‘Animal-derived’ substances and/or declaration about risk of Bovine Spongiform Encephalopathy / Transmissible spongiform Encephalopathy (‘BSE’/’TSE’)
e) Nanomaterials that are intentionally added
f) RoHS statement about RoHS restricted substances that are not intentionally added above the applicable threshold limits.
g) Standard declarations such as food contact
3) Summary of tests performed on the supplied (or similar) products such as biological evaluation (e.g. USP 87, 88, ISO10993), USP661.1, and ICHQ3D/ USP232 elemental impurities.‡
4) Management of Change notification commitment.
What cannot be provided by MPPE material suppliers
1) A statement of ‘compliance’ with MDR or IVDR.
• As with all other medical device or pharmaceutical packaging regulations the responsibility for compliance is with the company who is putting the product on the market.
2) A statement of “does not contain” for the following reasons:
• The information is not available unless a confirmation has been received from upstream suppliers and/or the supplied product has been tested. In many cases, the upstream suppliers (e.g. of chemical substances pigments, additives used in the plastics) have no obligation to provide information on substances they use, or impurities unless there is a legal requirement. The MDR and IVDR puts the legal responsibility with the end device manufacturer not with the supply chain.
• The practicality and reliability of the such ‘’does not contain ‘’ statement is also questionable due to the fact, a change in process by upstream suppliers, or a change of supplier, may not result in a change in CAS Nr, but could change the impurities. Finally, the ingredients, residuals and impurities in plastic parts, polymer compounds and masterbatches are probably modified by downstream processes.
• The information on composition of individual raw materials may be considered as confidential information by upstream suppliers, and therefore cannot be divulged downstream.
3) Full compositional information of our products to companies other than the end manufacturer of the device who has the responsibility to provide the dossier to the Notified Bodies.
• The compositions of products are the intellectual property and proprietary information of the supplier.
• A signed non-disclosure / confidentiality agreement is usually required.
4) Entries into non-standardized databases, spreadsheets or other company-specific forms.
• The administration requirements of supporting hundreds of individually designed company-specific forms are too high.
• Many of the forms are requesting ‘yes /no’ answers to ‘does not contain’ lists. As explained above this is not possible.
In conclusion, MedPharmPlast Europe is committed to working with other healthcare industry stakeholders both within and external to Europe to support practical implementation measures for various regulations.
Our objective is, through the connections to regulatory bodies and the collective knowledge of our members, to work towards practical measures to help enable safe and innovative treatments.