SGS rounds up the latest Q1 updates on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR).
Despite some reasonable progress with the implementation work around MDR & IVDR during the last few months, the unprecedented COVID-19 situation is having a huge effect on medical devices and other businesses. We will continue to support our clients in a professional manner, and we have already been involved in the rapid fast-tracking of assessments and approvals for ventilator and other essential equipment.
The immediate impact is obviously where travel is temporarily restricted or access to sites and facilities to carry out on-site audits may be limited. In these circumstances, SGS will be extending its use of ICT in line with our contingency planning and we have developed a set of guidelines on how to deal with Medical Device audits during this extraordinary situation. The solution will involve remote audits to ensure that client’s existing systems and product certifications continue to be valid and managed in compliance with regulatory rules, in combination with follow up on-site audits delayed until it is possible to conduct them (see MDCG 2020-4 guidance for EU commission position on remote audit).
Remote auditing will focus on the mandatory areas for the Directives, including verifying (as at an on-site audit) that the critical regulatory processes are being maintained. This includes informing us, as your Notified Body of significant changes, unannounced audit procedures and contracts, registrations and vigilance, post market surveillance and post market clinical follow up, as relevant.
The basics of the QMS maintenance, such as internal audits, management review, objectives, complaints and CAPA will also be addressed.
Technical file reviews will continue as normal, as these are completed remotely, in line with the established sampling plans for each client.
Unannounced audits, as they must be carried out on site, will be delayed until restrictions are lifted.
Latest News on Date of Application for MDR
On March 25, 2020, the EU Commission announced that work on a proposal to postpone the application date of MDR for one year is ongoing. Their goal is to submit this proposal in early April so the EU Parliament and Council can adopt it prior to May 26, 2020. Their aim is to take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. The EU Commission clearly stated that this will not affect the timelines for IVDR.
It should be noted that this is a proposal only, although likely to be carried forward, but manufacturers should continue to check the EU Commission website for updates. This will clearly have benefits for manufacturers to continue to place current devices on the market under MDD but until decisions are confirmed and we have more details, SGS is not yet able to define and explain what we will be able to do under such a postponement. Again, clients should continue to check the SGS medical devices website for updates. In the meantime, manufacturers should continue to work on meeting the compliance requirements of the new MDR/IVDR as an urgent priority.
With the Brexit date finally being reached on January 31 this year, SGS had already successfully mitigated the issue with the expansion of the MDD designated scope of our SGS Belgium Notified Body 1639 in November 2019. Successful migration of MDD certificates was completed by March 2020, to ensure the ongoing support for all clients.
We are currently focusing on MDR designation for SGS Belgium Notified Body 1639 and are now in the final stages. Experience from this designation process will help us to attain IVDR designation afterwards. Expectations from Belgian Competent Authority (FAHMP) lead us to anticipate MDR designation before end of 2020 but given the current COVID-19 crisis, SGS will continue to update clients on the progress.
The UK Competent Authority, MHRA, has confirmed that all CE certificates delivered by a UK notified body (SGS NB0120) will remain valid at least until December 31, 2020, provided that the “Valid until” date on the certificate is after December 31, 2020.
The MHRA communicated to SGS at the end of February 2020 that EU Authorized Representatives (AR) based in the UK will still be recognized until the end of the transition period (December 31, 2020). Therefore, if your EU AR is based in the UK, and if you want to continue selling your medical devices in the European Union after the end of 2020, you must find a new EU AR based in one of the 27 member states of the European Union. If your EU AR is based in Switzerland or in Turkey, you should also review their use and the potential to change to one based in the EU, as these two countries presently have no recognition covering MDR or IVDR although talks between the EU and Switzerland are presently on-going. The manufacturer's labelling must be compliant with the new details after this at the end of 2020.
European MD and IVD Regulations Corner
The various working groups within the EU commission are continuing to work on multiple subjects needed to implement MDR and IVDR. Their work program has been recently updated in February, once again to focus on the critical topics first and they continue to publish new guidance documents.
Since our last update newsletter at the end of 2019, the following documents have been published:
1.) Second corrigendum to the Medical Devices regulation (EU) 2017/745, on November 25, 2019. This is primarily correcting some minor typographic errors but also includes the following:
- Class I devices - gives a conditional and maximum additional four-year period of time to all Class I manufacturers to comply with MDR requirements and get a Notified Body involved in the conformity assessment of their devices that are class I devices under MDD but will need a CE certificate under MDR because either the device:
- needs reclassification to class IIa, IIb or III under MDR or
- is class I reusable devices under MDR
One of the major conditions imposed is that there are no significant changes in the design and intended purpose of these devices.
- EUDAMED database - Delaying requirements associated to EUDAMED to 18 months after the date EUDAMED will become functional, that is now planned as May 2022.
2.) MDCG 2019-14: Explanatory note on MDR codes in December 2019. Further guidance from EU on the codes defined in Commission Implementing Regulation 2017/2185, which establish the designation scope for notified bodies under MDR (EU) 2017/745.
3.)MDCG 2019-13: Guidance on sampling of devices for the assessment of the technical documentation in December 2019. This is an important document giving the sampling levels for Notified Body assessment of technical documentation for Class IIa and Class IIb devices under MDR, and Class B and C IVD’s under IVDR, based upon the “generic device groups” and “category of devices” defined in the respective Regulations.
4.) MDCG 2020-1 Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software in March 2020. Detailed guidance clarifying the latest interpretation from MDCG for software across both MDR and IVDR for the level of clinical evidence required.
5.) MDCG 2019-16 Guidance on cybersecurity for medical devices in December 2019. Establishes the concepts as they apply to medical devices, as a new enhanced focus under MDR/IVDR and guidance for manufacturers on how to fulfil the relevant GSPR.
6.) MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) in March 2020. Provides details on the process that can be followed for Class I devices under the transitional period, providing a valid Declaration of Conformity can be issued prior to May 26, 2020.
7.) MDCG 2019-8 v2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices in March 2020. Explains purposes, requirements and responsibilities for implant card for member states, manufacturers and notified bodies.
8.) MDCG 2019-15 Guidance notes for manufacturers of class I medical devices in December 2019. Specific guidance for class I manufacturers, as well as where importers or distributors take on obligation’s incumbent on manufacturers, covering all basic regulatory areas of MDR.
9.) MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. Specific Guidance on what changes will be considered as significant in transition period which will require MDR certification to be obtained even if MDD certification is in place.
10.) MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI in March 2020 that is now explaining what the Basic UDI-DI is and when new UDI.DI must be allocated.
EU Commission announced on March 25 that EUDAMED launch will be postponed with a two-year delay compared to initial expectation, until May 2022. The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and all its different modules for the different actors have achieved full functionality and have been subject to an independent audit. Therefore, EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022. Manufacturers need to be aware that from the date of application of MDR, they will need to comply with all the relevant requirements (e.g. creation of SSCP) even if the ability to upload to EUDAMED is not yet available.
It should be noted that the requirement for SRN’s will still be required, the EU Commission are hoping that this specific module in EUDAMED will be ready by May 25, 2020. However, if it is not, then each manufacturer will require to use the medical device registration processes of their Competent Authority or, for those manufacturers based outside of the EU, the Competent Authority of the location of their EU Authorized Representative.
There has been a concerted and urgent process for the adoption and publication in the Official Journal (OJ) of three Commission Implementing Decisions on harmonized standards, covering MDD 93/42/EEC, AIMD 90/385/EEC and IVDD 98/79/EC. The aim is to provide manufacturers of medical devices with the most updated state-of-the-art technical solutions, given that revised harmonized standards play a pivotal role in the current coronavirus crisis, because they relate to critical devices such as medical face masks (EN 14683:2019), surgical drapes and suits (EN 13795:2019), washer-disinfectors (EN ISO 15883:2018), sterilization (EN ISO 13408:2018 and EN ISO 25424:2019), etc.
Some of these standards, related to such critical devices are made freely available on the website of the European Commission.
The implementing decision (EU) 2020/437 applying to MDD was entered into force on March 25 after its publication in the OJ, and can be found here.
Similarly, the implementing decision (EU) 2020/439 applying to IVDD was entered into force on March 25, after its publication in the OJ, and can be found here.
These decisions apply until May 26, 2024.
SGS MDR & IVDR Training
SGS has developed some training to accompany you to MDR & IVDR:
- e-Learning modules for a quick overview on MDR and IVDR
- e-Learning Training course on IVDR Technical Documentation requirements – coming soon
For more information, please contact:
Global Product Manager - Medical Devices Regulation
t: +41 22 739 98 58
Global Product Manager - IVDR
t: +44 (0) 19 345 22 917