Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) provide for regular unannounced audits – as already established under Directives 93/42/EEC (MDD) and 98/79/EC (IVDD). This also applies to the “appropriate monitoring” of legacy devices in accordance with Article 120 MDR or Article 110 IVDR, which are still placed on the market under the respective Directive.

To ensure these audits run smoothly, it is important for us to know when your production is taking place and when downtimes are planned.

On our new page “Notification of production or non-production periods”, you can now easily provide us with this information using the integrated calendar function.
This ensures that unannounced audits can take place during active production phases.

Go directly to the new feature:
https://www.mdc-ce.de/en/service-portal/notification-of-non-production-periods-or-production-times/ 

• An overview of typical errors in the submission of technical documentation
• Practical guidance on how to avoid common pitfalls
• All information compiled in a single downloadable document

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR.

However, in the event of non-significant changes that require an amendment to the declaration of conformity (e.g. change of name, change of address), the existing declaration of conformity is supplemented by an addendum or annex in accordance with the directive.

This has now been clarified by the German market surveillance authorities (AGMP) and it is particularly pointed out that there may NOT be a new declaration of conformity according to MDD/ IVDD, but only a “supplement” (see above) to the declaration of conformity issued before 2021-05-26 (MDD)/ 2022-05-26 (IVDD), which clearly states the non-significant changes (e.g. also new product variants).

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR.

However, in the event of non-significant changes that require an amendment to the declaration of conformity (e.g. change of name, change of address), the existing declaration of conformity is supplemented by an addendum or annex in accordance with the directive.

This has now been clarified by the German market surveillance authorities (AGMP) and it is particularly pointed out that there may NOT be a new declaration of conformity according to MDD/ IVDD, but only a “supplement” (see above) to the declaration of conformity issued before 2021-05-26 (MDD)/ 2022-05-26 (IVDD), which clearly states the non-significant changes (e.g. also new product variants).

Reminder for the necessity of the submission of Periodic Safety Update Reports.
With a certain frequency manufacturers of medical devices of risk classes IIa, IIb and III have to create a PSUR (Periodic Safety Update Report) according to MDR Art. 86 and manufacturers of In-vitro-Diagnostics of risk classes C and D have to create a PSUR according to IVDR Art. 81. For MDR-/ IVDR-certified devices these PSURs have to be submitted to the Notified Body and will be assessed by it according to the requirements.

MDCG 2022-21 contains comprehensive explanations regarding the content of the PSUR for medical devices.

For MDR-/ IVDR-certified devices for which mdc did not receive a PSUR yet (in consideration of the period of creation), mdc will contact the manufacturers to remind the necessity and deadlines.

By today’s publication in the official European database NANDO, the list of Notified Bodies under Regulation (EU) 2017/746 (IVDR) has grown by another position with mdc medical device certification GmbH.
With today’s publication in the European database NANDO, we as a Notified Body have received the official designation under Regulation (EU) 2017/746 (IVDR). The regulation, adopted in 2017, applies throughout the EU and replaces the former Directive 98/79/EC. After several years of extensive preparation, review and approval, we are very proud to have reached this important milestone for us and our customers. The management of mdc would like to thank all employees who have contributed to the achievement of this goal in the company’s history and all customers for their loyalty during the long application phase.

We are very much looking forward to being your competent partner for the CE marking of your products also under the new regulations and are at your disposal for corresponding inquiries.

Contact: ivd(at)mdc-ce.de

With the position papers MDCG 2022-4 and MDCG 2022-15, Notified Bodies are requested to identify relevant certificates (under Directive 93/42/EEC and 98/79/EC) which are subject to surveillance according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR. The requirement for adequate surveillance of existing legacy devices1/2 by Notified Bodies is sharpened and should be reflected in the audit. This means that the following aspects will become a focus of the audit:

• Transition strategy to MDR / IVDR
• Assessment of (non-) significant changes according to MDCG 2020-3 or MDCG 2022-6
• Adjustments of the requirements according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR in the QMS (including post-market surveillance (Annex III of the MDR / IVDR), market surveillance, vigilance and registration of economic operators and devices)
• Assess whether all appropriate processes related to post-market surveillance, including risk management and performance data, are included in the post-market surveillance plan

For manufacturers, in addition to maintaining the QM system, all requirements must be implemented or mapped.

1Products placed on the market under Article 120(3) of the MDR after the date of application of the MDR (26 May 2021) and until the end of the transitional period on 26 May 2024, provided that certain conditions are met.

2Products placed on the market under Article 110(3) of the IVDR after the date of application of the IVDR (26 May 2022) and until the end of the respective transitional period referred to in the second or third subparagraph of Article 110(3), provided that certain conditions are met.

By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the date of application for „in-house devices” to 26 May 2028. Even though the main date of application remains on 26 May 2022, the new legal framework allows for longer transition periods for in-vitro diagnostic medical devices, which are already on the market:

• Certificates issued by Notified Bodies under Directive 98/79/EC will expire on 27 May 2025 at the latest. This means that devices, which are certified by a Notified Body according to Directive 98/79/EC, may be placed on the market until 26 May 2025.
• Legacy devices, which are covered prior to 26 May 2022 by a valid Declaration of Conformity according to Directive 98/79/EC and are placed on the market without involvement of a Notified Body can continue to be placed on the market until the following deadlines, depending on their classification:

1. 26 May 2025 for class D devices;
2. 26 May 2026 for class C devices;
3. 26 May 2027 for class B devices;
4. 26 May 2027 for sterile class A devices.

Additionally, deadlines for making available on the market and putting into service have been defined.

For the handling of changes of devices, which are placed on the market under Directive 98/79/EC, we expect a guidance document similar to 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)

The requirements of the IVDR regarding post-market surveillance, market surveillance, vigilance as well as the registration of economic operators and devices will apply to all in-vitro diagnostic medical devices from 26 May 2022.

The establishment of the company mdc medical device certification GmbH was commercially registered 25 years ago on December 10, 1996.

Already since 1994 “mdc medical device certification” was the name of a division of Dr. Müller-Lierheim GmbH and became legally independent when the company was founded in 1996.

Since the merger with the certification body for medical devices of ZDH-ZERT e.V. in 2000, mdc is based in Stuttgart. Further office locations are in Berlin, Tuttlingen and Vienna. In addition, the first non-European branch will be opened in Haifa (Israel) in a few weeks. In the past 25 years the number of employees has increased from three to over 100. In addition, there are around 70 freelance auditors, technical experts and inspectors. The daughter company of ZDH-ZERT e.V. is in the meantime not only one of the leading notified bodies and prequalification bodies, but is also the market leader in Germany regarding certification of QM systems in the area of medical aids .

mdc has always focused its activities on the field of medical devices and related areas. The range currently covers the activity as a notified body under Regulation (EU) 2017/745 for medical devices (MDR) and under Directive 98/79/ EC for in-vitro diagnostic devices (IVDD), as an accredited certification body for QM systems according to ISO 13485 and ISO 9001, as well as an accredited prequalification body in the field of medical aids. Recognitions in Ukraine and Taiwan, audits under the Medical Device Single Audit Program (MDSAP) within the framework of a cooperation and the organization of public face-to-face and online seminars on topics related to quality management and regulatory affairs complete the offer. Under Regulation (EU) 2017/746 (IVDR) mdc is at an advanced stage of the designation process.

On the occasion of the 25th anniversary of the company, the managing director Harald Rentschler, who took up this position when the company was founded, was handed out a honorary certificate from the Chamber of Industry and Commerce in Stuttgart by its the managing director Dr. Susanne Herre. He thanks everyone who has accompanied the company on its successful path.