Regulatory Affairs News

Get the latest news on medical device regulation

11.04.2024

European Commission

A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:

 

SCHEER

The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:

  • the evaluation of possible alternatives for phthalates used in medical devices, including alternative materials, designs, or medical treatments,
  • the methodology for performing a benefit-risk assessment, justifying keeping the presence of CMR and endocrine-disrupting phthalates at percentages above 0.1% w/w.

 

Swissmedic

New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation

21.03.2024

EU-CH negotiations

Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:

Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.

 

European Commission

MDCG just published its MDCG guidance development plan for 2024

  • Amongst the new, long-awaited documents: updated Vigilance forms, extended guidance on PMS and Vigilance for IVDs, guidance on IVD borderline issues and even RUO (Research Use Only), and guidance on Master UDI-DI.
  • Also, extensive work on documents for notified bodies is expected in Q2 2024.
  • And, for software, a “targeted revision” of MDCG 2019-11 (relative to medical device software qualification and classification), FAQs on the interrelation of EU MDR/IVDR and the new AI Act, as well as new guidance on the legal status of app providers, all three due by Q4 2024, sound promising.
14.03.2024

European Commission

Published updates to Harmonised Standards (HS):

  • Implementing Decision (EU) 2024/815 on HS under the EU MDR with updates to:
    • EN 455-3:2023 (on single-use gloves),
    • EN ISO 10993-15:2023, EN ISO 10993-17:2023 and EN ISO 10993-18:2020 (on biological evaluation),
    • EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized devices),
    • EN ISO 17664-2:2023 (on reprocessing).
  • The consolidated HS list is now also available: Summary list EU MDR
  • Implementing Decision (EU) 2024/817 on HS under the IVDR with updates to:
    • EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized IVDs)
  • The consolidated HS list is now also available: Summary list IVDR

 

MDCG 2024-3: Clinical Investigation Plan

  • Details provided about the content of the CIP
  • The template of CIP synopsis is provided in the Appendix

This MDCG guidance document was already generically referenced in revision 1 of MDCG 2021-6 issued in December 2023. Another generic reference concerns an MDCG guidance document on the Investigator’s Brochure, which is expected to be published soon.

 

Updates to the dashboard for Notified Body survey on certification and application (EU MDR/IVDR)

  • Average timeframe to sign a written agreement: 62% take less than 2 months
  • Time to reach a new Certificate: QMS 6-12 months, QMS + Product 13-18 months

 

European Parliament

Artificial Intelligence Act adopted as Regulation on 13-Mar-2024:

  • European Parliament officially approved the AI Act
  • is now subject to final lawyer-linguist check
  • will enter into force 20 days after its publication in the Official Journal, and be fully applicable 24 months after it enters into force

 

MedTech Europe

Position paper regarding the Industry perspective on the final AI Act published on 13-Mar-2024. Main requests:

  • Timely EC guidelines for the applicability of the AI Act to the medical technology sector, involving also key stakeholders (i.e. MDCG)
  • Support for the single conformity assessment and technical documentation
  • Clear pathway for clinical/performance evaluation. They express the concern that CE marking under the AI Regulation would be required before investigational devices or IVDs for performance studies can be used in pre-market studies under the EU MDR or IVDR.

 

Proposal for “One Substance, One Assessment” package published on 14-Mar-2024. Main aspects:

  • Concept of ‘One Substance, One Assessment’
  • Propose optimizing the package of legislations for OSOA
  • Consider the new role of ECHA, clarify the interface between REACH and RoHS (preventing regulatory overlaps)
07.03.2024

IMDRF

IMDRF Adverse Event Terminology (AET) codes have a new release in February 2024, including:

  • Annex A: Added 6 new terms and modified 4 terms.
  • Annex B: No change
  • Annex C: Added 1 new term.
  • Annex D: Added 2 new terms and modified 2 terms.
  • Annex E: Added 46 new terms and modified 12 terms and retired 1 term
  • Annex F: Added 5 new terms and modified 1 term.
  • Annex G: Added 1 new term and modified 1 term.
29.02.2024

Swissmedic

Switzerland-Liechtenstein collaboration in medical device surveillance

Swissmedic and the Office for Health of the principality of Liechtenstein signed a new agreement regulating collaboration on clinical investigations, medical devices, and in vitro diagnostic medical device surveillance in the Customs Treaty area (Switzerland/Liechtenstein economic area)

24.02.2024

Swissmedic

Information sheet on CAPA for Economic Operators

  • Intended to support economic operators of medical devices in the development of CAPA plans to address Swissmedic’s findings during inspections, based on the Deming’s cycle (Plan-Do-Check-Act).
  • Swissmedic reminds economic operators that they must proactively identify deviations from legal requirements at all times, independently of the market surveillance by authorities.

 

Team NB

Position paper on Classification of SARS-Cov-2

  • Under MDCG 2020-16 (currently, rev. 2 of February 2023), IVDs for SARS-CoV-2 correspond to Class D IVDs, per Rule 1 in IVDR Annex VIII.
  • Team-NB considers that the current level of risks associated with COVID, which are lower than during the pandemic, warrants a reclassification:
    • Recommended Class C, per Rule 3c
    • Potential further reclassification to Class B, per Rule 6, once more data on the post-pandemic phase, especially regarding the long COVID syndrome, are available.
  • This Team-NB position paper is expected to trigger another review of MDCG 2020-16.

 

European Commission

Second call for EU reference laboratories for high-risk IVDs

  • The EU Commission is considering launching a second call for applicants because no EU reference labs could be designated for the remaining 4 categories of Class D IVDs (arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping).
  • Interested laboratories are invited to informally express interest to their Member State by 30 April 2024.

 

EU Council endorses the proposed EU MDR & IVDR amendments

  • EU Parliament and Council shall be adopting the amendment to the EU MDR and IVDR.
  • Final text for the amending Regulation agreed: 2024/0021(COD).

 

US FDA

US FDA aligns QMSR with ISO 13485:2016

  • On January 31st, US FDA published the final rule amending cGMP (current Good Manufacturing Practice) in their Quality Management System Regulations (QMSR) to align more closely with ISO 13485:2016: the Quality Management System Regulation (QMSR) Final Rule.
  • This was an expected and significant step forward in international alignment.
15.02.2024

EUDAMED

EUDAMED User Guide and templates v. 2.14 updated:

UDI Devices Module

  • Certificate and SSCP/SSP information can be found in Basic UDI-DI section.
  • Bugs fixed

NB & Certificates Module

  • Newly added functions related to registering SSCP/SSP and linking Basic UDI-DI
  • Hyperlink of Basic UDI-DI from NB & Certificate module to UDI/Device module will be automatically updated
  • Indication the validation of the new SSCP/SSP master document is required (NB’s obligation)
  • Bugs fixed

Data Exchange

  • Include the information on inactivation of the SSCP/SSP and related certificates in the payload when downloading.
  • Bugs fixed

 

EU Health Technology Assessment (HTA)

Updated rolling plan for the implementation of Reg. (EU) 2021/2282 on HTA published on 6-Feb-2024.

Fifth information stakeholder event planned for 09-Apr-2024: From Theory to Practice – Implementing the EU HTA Regulation

Video recordings of the stakeholder event held on 30-Jan-2024 available from the event webpage: From Theory to Practice – Implementing the EU HTA Regulation

Topics discussed:

  • Understanding key elements of the EU HTA Regulation
  • Challenges and opportunities in the implementation process
  • Involving stakeholders in EU HTA implementation
08.02.2024

European Commission

MDCG 2024-2 Procedures for the updates of the EMDN:

  • The Nomenclature Working Group (NOM WG) is responsible for the use of EMDN
  • Annual revisions of the EMDN – 4 phases throughout the year
  • Expedited review for ad-hoc updates of the EMDN
  • platform for EMDN requests (visualization of existing EMDN codes less user-friendly than in previous website version)

 

Swissmedic

New timelines for swissdamed release:

  • Actor (ACT) module for registration of economic operators – 2nd half of 2024 (instead of 1Q2024)
  • UDI module to register devices – available 4 months after the ACT module’s go-live

 

Notified Body

BSI FAQs on EU MDR transition (new version)

  • Clarification on renewal of the old certificates, NB’s confirmation letters, NB transfers due to MDR transition, changes to “legacy devices”
  • Clarification of MDR application with BSI

Notified Bodies Survey on certifications and applications – Status Oct. 2023

  • Update status by October 2023
  • All NB surveys presented in The Dashboard

 

COCIR

Joint statement in support of the extension of e-IFU for medical devices (2-Feb-2024)

  • Proposal for an update to the scope of Reg. (EU) 2021/2226 for specific product categories
  • Highlights advantages of e-IFU for professional use
01.02.2024

European Commission

Published MDCGs for Device Specific Vigilance Guidances Templates:

  • A general explanation of the report criteria for serious incidence, PSR, and Trend Report
  • Guidance for reporting and IMDRF codes

MDCG 2024-1 Device Specific Vigilance Guidances (DSVG) Template

 

Swissmedic

Published checklist (available only in German and French) in support of the Swiss Guideline for the validation and routine monitoring of cleaning and disinfection processes for medical devices, intended as an aid for healthcare professionals who check the annual validation reports of instrument washer disinfectors and trolley washer-disinfectors.

26.01.2024

European Commission

Draft amendment to EU MDR and IVDR via Commission proposal for extended transition periods for legacy IVDs, early EUDAMED deployment and mandatory notification of device supply interruption:

  • New obligations for manufacturers to notify the relevant competent authorities, economic operators, and healthcare institutions/professionals of critical discontinuation of medical devices and IVDs. Concerned economic operators having received such notification shall forward it further down the distribution chain.
  • Early mandatory use of already available EUDAMED modules – Q4/2025
  • New transition periods for legacy IVDs
    • Class D IVDs 31 December 2027
    • Class C IVDs 31 December 2028
    • Class A sterile and Class B IVDs 31 December 2029

Medtech Europe

Reaction to EC proposal to extend transition periods for IVDR

  • Acknowledges and supports any measures that keep devices available to the patients
  • Points out 4 important conditions to be met before EUDAMED modules are made mandatory (see joint open letter below)
  • Proposes that notification of critical device discontinuation should be as simple as possible

Joint open letter: In anticipation of EUDAMED availability for mandatory use

  • Listed the four preconditions to be med before EUDAMED would be made mandatory
  • National Databases should be phased out in favor of EUDAMED
  • Central and single sources of truth

Swissmedic

Published meeting notes for Roundtable on Medical Technology (RTMT) held on 11-Nov-2023

  • Swissdamed:
    • the Actor Module go-live in Q1/2024
    • product registration is planned for the summer 2024
  • Swiss Medtech – pointed out the differences in the need for the authorized representative for Procedure Packs and Systems in Switzerland vs. EU
  • Swiss Medtech – provided further feedback on FSC, incident reporting, manufacturer’s self-declaration, and introduced new problems (e.g. non-recognition of Turkish Notified Body)
18.01.2024

Swissmedic

New section on swissdamed: Questions and Answers

  • General questions and answers on registration information of CHRN, deadlines, and language-related questions
  • Some registration guidance questions but still no release of swissdamed

European Commission

Overview of national language requirements in EEA/Turkey for manufacturers of medical devices and IVDs: Language Requirements Table MDR and Language Requirements Table IVDR. Information in both tables about languages required at a national level for:

  • Relevant national legal provisions
  • Label/IFU
  • Implant card
  • DoC
  • FSN
  • Documents for conformity assessment
  • GUI (Graphic user interface)

A new version of the Joint implementation and preparedness plan for IVDR

  • General updates on contents related to MDCG guidelines
  • General updates on the status of actions
  • Newly added:
    • EURLs high priority action 3.7
    • Guidance for NBs high priority action 5.5, 5.6 & 5.7
    • Performance evaluation and expert panels action 6.5 & 6.6
    • Section 12 – “Orphan” device and action 12.1
11.01.2024

Swissmedic

Information sheet: CHRN v3.3

  • Layout renew
  • New contact detail

Information and assessment of CH-REP regarding the former notified body ECM

  • Targeted check – selected a sample of 15 SAR for assessment
  • 8 SAR do not have manufacturers with ECM certificates
  • 7 SAR do have manufacturers with ECM certificates. But no suitable measures had been taken by the SAR.
  • Swissmedic is ordering corrective measures for such SAR

European Commission

NB dashboard

  • Presents an overview of the data gathered from different stakeholders
  • Integrate comparable data from previous surveys of NBs conducted by the EC
05.01.2024

Swissmedic

New organisational structure with separate Medical Devices Surveillance Sector

  • Responsible for: safety of clinical trials, Vigilance (called “Materiovigilance”), and market monitoring of medical devices.
  • Also responsible for monitoring the maintenance and processing of medical devices in hospitals

Swiss legislation (new version 01.01.2024):

  • Federal Act on Therapeutic Products, TPA (SR 812.21): New Art. 14 §3 on labelling simplification plans for parallel imports of pharmaceuticals.
  • Data Protection Ordinance, DPO (SR 235.11): Updated Art. 41 to replace the name “National Center for Cybersecurity (NSCS)” by “Federal Office of Cybersecurity”.
  • Federal Act on Chemicals, ChemA (SR 813.1): New Art. 10a and Art. 25a relative to biocides
  • Ordinance on Reducing Risks of Chemicals, OChRR (SR 814.81): The updates are part of the bi-annual reviews of restrictions on chemical substances (the reviews are published in January and June).
  • Waste Ordinance, ADWO (SR 814.600): Updated Art. 15 §3 on recycling of phosphorus, per the updated OChRR.
29.12.2023

Swissmedic

Information Sheet: Clinical investigations with medical devices rev. 4.3

  • New references are added in Appendix A7 on in-house manufacturing in healthcare institutions.
  • Update on sending CIOMS forms for SUSAR (suspected unexpected serious adverse reactions) to Swissmedic in Appendix A7.

Information Sheet: Performance studies with IVD rev. 3.4

  • New references are added in Appendix A7 on in-house manufacturing.
  • Update on sending CIOMS forms for SUSAR (suspected unexpected serious adverse reactions) to Swissmedic in Appendix A7.
22.12.2023

European Commission

MDCG 2021-17 Rev. 1 on importers and distributors:

  • Clarification of the fact that the same entity cannot be both the importer and distributor of a given device
  • Clarification on the accompanying document that indicated importer details
  • Clarification on Procedure Pack or System Producer endorses an additional importer or distributor role if the producer is not the manufacturer of devices brought together

MDCG 2019-7 Rev. 1 on PRRC, provides clarifications for:

  • Demonstration of the evidence of qualification of the PRRC
  • The availability requirement of the PRRC (no need to be 24-hour available)
  • PRRC related to Art. 16(1) on the entity that repackages the devices
  • PRRC related to the entity reprocessing the single-use device
  • PRRC related to Art. 22(4) on Procedure Pack and Systems Producer

MDCG 2023-7 on Exceptions for clinical investigations per Art 61-4 to -6 and on ‘sufficient levels of access’ to data needed to justify claims of equivalence:

  • Table 1 of criteria for exemption from clinical investigations for implantable and Class III
  • Flowchart of consideration for (4) cases listed in Appendix I
  • Hierarchy of levels of access to the data to be considered for the demonstration of equivalence is listed in Table 2 in Appendix II

Team NB

NB’s Position Paper on Medical Device Lifetime:

  • Expectation and guidance documents of MD Lifetime
  • Consideration of different devices:
    • Active devices
    • Software devices
    • Implantable devices
    • Biological devices
  • Clinica data expected
  • Statistical analysis
  • Team-NB’s recommendations

Swissmedic

Frequently Asked Questions updates on Devices manufactured and used in healthcare institutions, new section added:

  • In-house IVD (according to IvDO)
  • Requirements according to Art. 5 Abs. 5 Bst. a-i EU IVDR
  • General Information for In-house IVDs
  • Further Obligations of healthcare institutions (vigilance, maintenance, cybersecurity, microbiological laboratories)

Information Sheet on Derogation:

  • Lists further data to be submitted as part of a derogation request.
  • The number of devices placed on the market in the last three years, the expected number of derogated products to be placed on the market, and the list of intended customers are now also required.

Product groups without an intended medical purpose page update:

  • Video explaining what are Annex XVI products
  • Video of transitional provisions in Switzerland and the legal requirements
14.12.2023

European Commission

MDCG 2021-6 Rev.1 – MDR Clinical investigations: More guidance by adding new questions and Annex III.

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products

  • Clarifications for qualification of accessories, dual-purpose devices, multiple intended purpose devices
  • Pratical issues of qualification are provided
  • Examples of products out of scope of Annex XVI products
  • Classification examples for 6 groups of devices

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: Clarification for the application of the clinical criterion to products w/o a medical purpose

BSI: Regulation of MD and IVD in Northern Ireland

  • MDR and IVDR apply in Northern Ireland, the MHRA (the Medicines and Healthcare Products Regulatory Authority) is the de facto Competent Authority for Northern Ireland.
  • No requirement for an NI manufacturer to appoint a UK RP or EU AR.
  • EU CE-marked devices can be sold in NI
  • GB-based manufacturers need EU AR or NI-based AR to sell devices in NI

Swiss Medtech: Guidance on regulatory requirements for optical frames

  • Guidance on distributor, importer, manufacturer
  • Examples for maintenance and repair
  • Regulatory requirements for maintenance and repair
  • QMS for opticians
  • Checklist to review the packaging and documents
07.12.2023

European Commission

Commission Implementing Reg. (EU) 2023/2713 – designating EU reference laboratories in the field of IVDs

The designated EURLs together cover the following categories of class D IVDs:

  • Hepatitis and retroviruses
  • Herpesviruses
  • Bacterial agents
  • Respiratory viruses that cause life-threatening diseases

The EURLs are expected to take up their tasks in the conformity assessment of devices on 1 October 2024.

Five EURLs have been designated.

23.11.2023

MedTech Europe/COCIR

16.11.2023

Swissmedic

BW690_00_001defi_FO Orders for export certificates for medical devices

  • New form version (v.1.3) for ordering of export certificates (Free Sales Certificates, FSC)
  • Watermark protection when uncompleted forms
  • No substantial changes

 

European Union

Reg. (EU) 2023/2482 amending REACH — Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:

  • 1 January 2029 as “Latest application date”
  • 1 July 2030 as the “Sunset date”, placing on the market and the use of the substance prohibited.
09.11.2023

MedTech Europe

Position paper – The Future of Europe’s Medical Technology Regulations

Ensuring efficiency, for example:

  • Considerably cut down on unnecessary bureaucracy in conformity assessment
  • Put in place a ‘pay for procedure’ model
  • Fully digitise the EU system
  • Permit digital labelling
  • More differentiation should be made between IVD class B and class C professional laboratory devices
  • Remove the limited validity of certificates

 

Embracing innovation, for example:

  • Early / pre-filing / pre-market dialogues
  • Create dedicated and accelerated assessment pathways
  • Improve the EU emergency use pathways
  • Adopt “pre-certification” access models
  • Adopt evidence requirements
  • Consider where devices can be brought through the European CE-marking system more quickly, based on regulatory
  • decisions taken by other jurisdictions

 

Effective governance, for example:

  • Taking system-level decisions
  • Driving a healthy ecosystem for medical technologies
  • Managing the decentralised network of Notified Bodies
  • Authoring guidance documents
  • Representing the system both within Europe and globally
  • Creating a structured, on-going stakeholder dialogue mechanism to identify needs for adapting the system
01.11.2023

The Swiss Ordinances on Medical Devices (MedDO, SR 812.213) and on In-vitro Diagnostics (IvDO, SR 812.219) that were revised to align with the new transitional provisions in EU MDR and IVDR have entered into force from 1 November 2023. Swissmedic has now published information about the implementation of these updates.

The Information Sheet on Economic Operators has been updated to remove outdated information and clarify some important topics.

  • A few obligations of Swiss importers/distributors are reworded for clarification. The duty to immediately forward complaints and reports about suspected incidents has been changed from “To manufacturer, if applicable to authorised representative” to “To manufacturer and to authorised representative”. Swiss importers and distributors have to “Keep a register” instead of “Keep a Complaints List”.
  • Per the new question (i), the Swiss importer must be clearly identifiable along the supply chain, even when there is no distributor. This is meant to clear doubts that might have arisen from the meaning of “document accompanying the device”, where it was indicated that it did not necessarily need to reach the end user.
  • For the extension of the validity of EC Certificates (non-IVD), both the CH-REP and the Swiss importer are responsible for checking the plausibility of the manufacturer’s self-declaration and/or the Notified Body’s confirmation letter under EU MDR Art. 120(3c).
    Note: No explicit reference is made to the possibility of placing on the market an EU MDR device and its “legacy” version in parallel. Yet, Swissmedic clearly states that they rely on the EU Commission’s practice on interpretation and points to their Q&A document. As such, question #2 in this document is presumed to apply in Switzerland, too.

Also, there is a new Information Sheet on Products without an intended medical purpose (i.e. those commonly known as “Annex XVI products”), clarifying that a CH-REP is not required for Annex XVI products as long as they are not yet placed on the market under the MedDO, i.e. due to the transitional provisions. However, professionals who use these products must report serious incidents to Swissmedic, and some timelines applicable to Annex XVI products differ in the MedDO, due to the time gap with respect to Reg. (EU) 2023/1194.
Swissmedic has also created a new website for these Product groups without an intended medical purpose.

Last, Swissmedic has updated the Information sheet on FAQ on IVD notification. IVD notification to Swissmedic only applies to Swiss-based manufacturers.

27.10.2023

European Commission

Commission Delegated Reg. (EU) 2023/2197 of EU MDR – the assignment of UDI for contact lenses

  • “Master UDI-DI” shall be assigned to contact lens products
  • Date of Application: 9 November 2025
20.10.2023

Swissmedic

Information sheet on FAQ on IVD notification – updated version

  • IVD notification to Swissmedic only applies to Swiss-based manufacturers.
  • This updated InfoSheet introduces new questions:
    • Question #15 on the procedure for completing the notification form for in-house IVDs
    • Question #16 on the declaration of in-house IVDs meeting GSPR requirements
    • Question #24 on Fees

Vigilance e-mail requirements clarification that need the attention of foreign manufacturers

  • The text on Swissmedic’s webpage relative to MIR has been updated with the following clarification:
    • In addition to specifying “CH-REP” in section 1.3.1 of the MIR form upon selecting “Other, please specify”, the CH-REP’s contact details must be indicated in section 1.3.4 of the MIR form.
    • The CH-REP’s e-mail address that has to be indicated in section 1.3.4d of the MIR form must be included in the mailing list when the foreign manufacturer (or System/Procedure Pack Producer) submits the MIR to Swissmedic.
  • The text on Swissmedic’s webpage relative to Trend report & PSR & PSUR has been updated with the following clarification: The CH-REP’s e-mail address that has to be indicated in section 1.3.4f of the Trend report form must be included in the mailing list when the foreign manufacturer (or System/Procedure Pack Producer) submits Trend reports directly to Swissmedic.
  • The text on Swissmedic’s webpage relative to FSCA has been updated with the following clarification: The CH-REP’s e-mail address that has to be indicated in section 5 of the FSCA form must be included in the mailing list when the foreign manufacturer or System/Procedure Pack Producer) submits FSCA reports directly to Swissmedic.
18.10.2023

European Commission

MDCG 2023-4 MDSW – Hardware (HW) working in combination

  • This new guidance document covers HW or HW components that play an essential role in the intended purpose of certain MDSW, particularly in medical mobile apps.
  • As expected, for MDSW that works in combination with HW or HW components placed on the market as either a medical device or an accessory to a medical device, the MDSW manufacturer must demonstrate compliance of the combination with the EU MDR, and establish communication channels with the corresponding HW and HW manufacturer for Vigilance purposes.
  • Now, when the HW or HW component (to MDSW) is NOT a medical device or an accessory to a medical device and has no intended medical purpose, the MDSW manufacturer becomes responsible for the safety, performance and reproducibility of the HW or HW component in their combined use with the MDSW, in all intended configurations.
    This means that, if you have a medical mobile app that interacts with a non-medical device wearable to capture physiological parameters of users/patients, which are then further analyzed/processed by your App, your risk management, clinical evaluation, and post-market surveillance must integrate the wearable. Given the limited leverage that an MDSW manufacturer might have over a third-party HW or HW component, this requirement could represent a show-stopper.

 

Swissmedic

Swissmedic inspection of Swiss importers

Swissmedic has published a summary report of its inspection of Swiss importers. There were deficiencies at 23 of the 30 inspected companies, regarding in particular:

  • the correct verification of the products
  • the indication of the importer’s contact details
  • the storage and transport conditions
  • The findings were presented by Swissmedic at Swiss MedTech’s National Conference Day on October 18th, as part of a session on How to prepare for Swissmedic’s inspections.
13.10.2023

EU Commission

The EU Commission’s proposal for a Directive on the liability of defective products is moving forward with the approvals of the Legal Affairs Committee (JURI) and Internal Market and Consumer Protection Committee (IMCO). For more details on the development of this important legislative piece, see the EU Parliament’s New Product Liability Directive briefing.

09.10.2023

Swissmedic

MedDO and IvDO are revised to align with the EU MDR transitional provision.

The new versions will come into application on 01-Nov-2023. Watch out for the upcoming Swissmedic’s related guidelines, expected to be published prior to the date of application.

02.10.2023

EU Commission

Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR published: provides clarification on the newly extended transitional provisions for products without intended purpose (“Annex XVI” products)

Manual on borderline and classification for medical devices under EU MDR and IVDR, updated with new cases:

  • Root canal irrigation solution
  • Temperature sensors embedded in orthopedic devices for compliance tracking
  • System intended to produce sclerosing foam
  • n-butyl-2-cyanoacrylate based adhesives
  • Custom-made cranial implant
  • Root canal irrigation solution
26.09.2023

Swissmedic

swissdamed survey results report published. A few interesting insights:

  • Preferred responsibilities for uploading device registration data: either by the CH-REP or by both CH-REP and the foreign manufacturer.
  • Foreign manufacturers should be authorized to maintain data (via CH-REP).
  • Excel as the preferred solution to upload data onto swissdamed.

English version of the updated MedDO and IvDO are now available.