Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2024/815 and (EU) 2024/817
11 March 2024
Harmonised Standards for Medical Devices: Further Amendment of Implementing Decision (EU) 2021/1182
On 8 March 2024, Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for single-use medical gloves, biological evaluation of medical devices, sterilization of healthcare products, packaging for medical devices to be sterilized in the final packaging and reprocessing of healthcare products was published in the Official Journal of the European Union.
Assessment of Regulatory Needs (ARN) Reports
15 February 2024
Cefic has just published a position paper on ECHA’s Assessment of Regulatory Needs (ARN) reports (Cefic, 2024).
What is ARN?
ARN is a preliminary step taken by the European Chemical Agency (ECHA) to explore the need for potential regulatory risk management for (groups of) substances. It is an informal, iterative screening of group of substances to help authorities address concerns in an optimal way.
How is grouping done? Is it same as read-across approach?
The groups from ARN are built upon available information and apply a practical approach to prioritise areas of interest based on common attributes like uses, hazards, and chemical structure, which differs from grouping as defined in Annex XI. ARN does not aim to validate read-across and category approaches.
Team-NB: Position Paper on Medical Device Lifetime
7 February 2024
The MDR does not provide a specific definition of the lifetime of a medical device. However, as part of the general safety and performance requirements (GSPR – Annex I of the MDR), the regulation imposes obligations on the manufacturer regarding the lifetime of the medical device. Other articles also refer to the lifetime of medical devices (Article 18 Articles 83 and 86 and Annex XIV Part B Sections 5 and 6 and Annex II (6)).
The position paper, published on 15 December 2023, intends to provide an overview of existing guidelines and standards and to illustrate the circumstances of various types of medical devices.
European Commission Issues Language Requirements for Medical Device Manufacturers
23 January 2024
On 17th January 2024, the European Commission published the overview of language requirements for the product information and instructions to be provided with medical devices (MD) and in vitro diagnostic devices (IVD) in the European Union. The overview tables (MD and IVD) should help manufacturers better understand which information in which languages needs to be provided in a specific country.
MDCG 2021-27, Rev.1, Guidance for Articles 13 (Importers) & 14 (Distributors) Published
10 January 2024
The Revision 1 of the guidance "Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746" of the Medical Device Coordination Group (MDCG) was published in December 2023.
The introduced amendments to the Guide 2021-27 on operational and practical implementation of Articles 13 and 14 and further related obligations for importers and distributors are listed on page 2 of the document. The obligations described in Article 16 are excluded, being addressed in other MDCG documents: MDCG 2018-6, MDCG 2021-23 and MDCG 2021-26.
The guide begins with the definition of importer and distributor. The decisive factor in distinguishing between these economic operators is the definition of placing on the market and making available on the market. When an operator makes a non-EU manufactured medical device available at the EU market for the first time, the operator becomes an importer with mandatory obligations (more detailed examples and special cases provided in the MDCG 2021-27 document). It is possible for a person to hold the roles of an authorised representative and an importer at the same time, provided the corresponding obligations are fulfilled. Individual stores, pharmacies or individuals can be regarded as potential distributors that also become importers with corresponding obligations as soon as they distribute medical devices from non-EU countries on the EU market for the first time. The obligation to affix the importer information to the product (product packaging or accompanying documents) lies with the importer. The distributor verifies the presence of the importer information on the product. Both distributors and importers are obliged to verify the requirements in accordance with Article 13(2) and 14(2) before placing medical devices on the market – verification methods are described in the guideline.
The MDCG 2021-27 document also addresses reporting obligations of both economic operators and obligations regarding EUDAMED registration. Importers and distributors are obliged to ensure the traceability of medical devices.
Amendment to KKDIK Regulation officially published
9 January 2024
A new legislation amending the Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals, known as KKDIK or Türkiye REACH, was officially published on 23 December 2023.
The amendment overrules the original registration deadline at the end of December 2023, by setting out a new timetable with staggered registration deadlines for chemical substances:
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Substances |
Deadlines | |
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31 December 2026 | |
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31 December 2028 | |
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31 December 2030 |
MDCG 2019-07 Guidance on Article 15 on the PRRC revised
9 January 2024
The Revision 1 of “Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)” of the Medical Device Coordination Group (MDCG) was published in December 2023.
The revised guideline on the tasks and responsibilities of the PRRC intended for manufacturers, authorised representatives and PRRCs, contains some corrections and additions (see page 2 of the document). Manufacturers (and authorised representatives) are obliged to appoint a PRRC that meets the qualifications of Article 15. Both manufacturers and PRRCs are obliged to register with EUDAMED. Manufacturers must employ a PRRC on a permanent basis (with exception of small and medium-sized enterprises), whereas authorized representatives must only have permanent access to a PRRC.
The guideline specifies the necessary qualifications of PRRCs and the requirements for custom-made medical devices. It also addresses the location of the PRRC (inside or outside the EU) and the number of PRRCs in organisations consisting of parent companies and subsidiaries. Authorised persons and the role of the PPRC are not to be filled by a single person. The obligation to appoint a PRRC also applies to importers, distributors or other legal entities assuming the obligations of a manufacturer (Article 16(1)).
Most importantly, the MDCG 2019-07 document breaks down the responsibilities of the PRRC, mentioned in Article 15.3, by comparing them with the obligations of manufacturers in Article 10. It also provides guidance on the fulfillment of the PRRC’s obligations emphasizing that PRRCs must not be disadvantaged by the dutiful fulfillment of their tasks within the company.
Merger of Agrochemicals and Biorationals – Integrated Pesticide Use in EU
8 January 2024
Our regulatory experts took a closer look at the recent developments on the European crop health and nutrition market by putting them into context with the EU agricultural goals, current trends, future potential and legal aspects. The full article is available on AgroPages news website.
Team-NB: Position Paper on Medical Device Lifetime
8 January 2024
The MDR does not provide a specific definition of the lifetime of a medical device. However, as part of the general safety and performance requirements (GSPR – Annex I of the MDR), the regulation imposes obligations on the manufacturer regarding the lifetime of the medical device. Other articles also refer to the lifetime of medical devices (Article 18 Articles 83 and 86 and Annex XIV Part B Sections 5 and 6 and Annex II (6)).
The position paper, published on 15 December 2023, intends to provide an overview of existing guidelines and standards and to illustrate the circumstances of various types of medical devices.
Existing guidelines and standards dealing with the topic of the service life of medical devices are e.g: MDCG 2022-21, MDCG 2020-8, IMDRF Technical Document on Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices and EN ISO 20417:2021 (Medical devices — Information to be supplied by the manufacture).
The position paper addresses various scenarios, taking into account other existing standards and different types of medical devices (e.g. software, implants or active medical devices), with risk assessment and post-market surveillance as an essential part of it.