A very eventful year lies behind us. The Corona pandemic had a massive impact on all areas of life and is still not over yet. Beyond this it has also affected the medical device sector in many ways.

Who would have expected in February 2020 that the long announced date of application of the Medical Device Regulation (MDR) would be postponed by one year? Who would have thought 8 months ago that audits could also be conducted as remote audits? Beyond this also Brexit continues to present us with large challenges.

Distribution of devices in the UK market will be more difficult. The new EU Medical Device Regulation (Regulation 2017/745, MDR) as well as the In Vitro Diagnostics Regulation (Regulation 2017/746, IVDR) will not be adopted to UK regulatoins. Due to Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA), as the responsible authoriy in the UK, has published newly adopted rules for the UK market that will apply for placing of medical devices on the UK market from 2021 on. The guidance on regulating medical devices in the UK provides details on the changes starting January 1, 2021, and the transition periods that will apply in the future.

The most important information at a glance:

UKCA marking: as of January 1, 2021, the new UKCA mark was introduced to replace the CE marking in the medium term. Within the risk class-specific transition periods (at the latest by June 30, 2023), the marking can already be used voluntarily. From July 1, 2023, the UKCA label will be mandatory for all products in the UK market (with the exception of Northern Ireland). The current requirements for UKCA labeling are based on the requirements of the European Directives (MDD and IVDD). Nevertheless manufacturers should expect a higher administrative burden.

• Conformity assessments by Notified Bodies based in the EU, however, will continue to be valid during the transition periods for market access in the UK.
• Registration of all medical devices: Staggered by risk class, registration of all medical devices with the MHRA will be mandatory from January 1, 2021. Registration of all devices from January 1, 2021 is therefore recommended. You will find all relevant deadlines here.
• Designation of a Responsible Person: manufacturers without a subsidiary in the UK are required to designate a Responsible Person. However, it is possible for importers or distributors to take on this role in consultation with the manufacturer.
• Special status for Northern Ireland: In Northern Ireland, the EU medical device regulations continue to apply with all known transition periods. Thus, both the Directives and MDR and IVDR will be applied in Northern Ireland, although these regulations will no longer be valid in Great Britain. For the Northern Ireland market, the use of the CE marking will therefore also continue.

The new regulations that have come into force for the UK market are currently posing new challenges for all parties involved. mdc is intensively dealing with the requirements necessary in Europe and is examining the necessary steps and possibilities in order to also be able to offer such certification. We will inform all mdc customers in due time.

Stay healthy!

Your mdc team

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

As of today (2021-05-26), Regulation (EU) 2017/745 on medical devices (MDR) represents the applicable legal framework for medical devices. This is supplemented by national laws (e.g. in Germany the MPDG or in Austria the MPG 2021). However, Directive 93/42/EEC (

MDD) is no longer applicable and has been superseded by the MDR (see news article dated May 18, 2021).

mdc has already been designated as a Notified Body according to MDR since 2020-04-25; thus we can continue to offer our customers the necessary certification for market access for medical devices!

Certificates according to Directive 93/42/EEC remain valid – for the period of validity indicated on the certificate! In this context, we would like to remind you that for placing medical devices of class III on the market, both a valid certificate on the quality assurance system (e.g. according to Annex II, without Section 4 MDD) and a valid certificate on the product design (e.g. according to Annex II, Section 4 MDD) are required. A certificate according to MDR (e.g. about the quality management system according to Annex IX, chapter II MDR) is not a sufficient substitute.

For the maintenance of MDD certificates under the MDR we refer to the news article of 08.03.2021.

Market Approach:

According to the latest information the customs agreements with Turkey could be adjusted in due time. This means that Turkish manufacturers can also continue to participate in the European market.

Due to the start of validity, some trade agreements between the EU and other states lose their validity. For example, the Mutual Recognition Agreement with Switzerland has not been extended, and Switzerland is considered a third country. This means that Swiss manufacturers need a European authorized representative, and must also indicate this on the labeling. Likewise, EU manufacturers must indicate a Swiss authorized representative based in Switzerland for export to Switzerland.
However, no transition periods have been defined, so these requirements apply to all products that are placed on the market for the first time after DOA (i.e. 26.05.2021, 0:00).

Already at the beginning of 2021, the United Kingdom has left the European Union, with far-reaching consequences for the market access of British manufacturers in the EU (necessity of a European Authorized Representative) as well as with consequences for EU manufacturers for the British market access (UKCA marking, at the latest from 30.06.2023), see also our news article from 28.01.2021.