Regulatory Affairs News

MedTech Europe/COCIR

• MedTech Europe and COCIR are partnering to present a joint medical technology industry perspective on the final agreement of the Data Act.
• There are no substantial changes.

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.

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

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The Information Sheet on Economic Operators has been updated to remove outdated information and clarify some important topics.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

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

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.

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.

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.

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.

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

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.