Question to the EU Commission: EU Medical Device Regulation

Queston for written answer E-001632/2021
to the Commission
Rule 138
Lars Patrick Berg (ID)

Subject: EU Medical Device Regulation

The Baden-Württemberg state government is calling on the Commission to support facilitations in the implementation of the EU Medical Device Regulation (EU MDR). With over 800 companies and a turnover of some EUR 14 billion, Baden-Württemberg is one of the leading locations for medical technology in Europe. Companies in the Schwarzwald-Baar-Heuberg region in particular are among the drivers of innovation[1]. Inhibitory, contradictory interpretations of the EU MDR are jeopardising this success.

1. What is the Commission’s assessment of Baden-Württemberg’s call for the outstanding significance of the location for medical technology in Europe to be reinforced by means of immediate assistance and support in the implementation of the EU MDR?

2. What flaws does the Commission see in the published guidelines for the EU MDR, and how does it intend to improve these to ensure that Baden-Württemberg is not put at a competitive disadvantage internationally?

3. How will the Commission guarantee the security of supply of medical products for the EU in future?


Answer given by Stella Kyriakides
on behalf of the European Commission

1. The Commission has been promoting strong collaboration and consultation of competent authorities for medical devices legislation and relevant European based associations of economic operators since May 2017, date of entry into force of Medical Device Regulation (MDR)[1]. While recognising that MDR requirements are more stringent than the existing legal framework, which is in place since early nineties, the objectives of new legislation is adaptation to scientific progress and a higher level of protection for patient safety.

2. The Medical Devices Coordination Group (MDCG[2]), which is a Commission Expert Group, has endorsed a substantial number of guidance documents further to consultations with Member States’ representatives and relevant EU associations representing economic operators. This guidance is not legally binding but aims at facilitating a harmonised approach as regards implementation of the new legal framework. MDR is a modern legislation accommodating updated requirements that allow medical devices with CE marking to gain — or maintain — a significant competitive advantage at international level.

Effective implementation of the MDR, is essential to secure the supply and availability of safe medical devices. There have been some progress in the designation of Notified Bodies over the last year and we now have 20 notified bodies designated under MDR. A number of safeguards to ensure availability of devices are also included in MDR, including transitional provisions allowing a large number of devices to remain under the current Medical Device Directives until May 2024 and, as a last resort, possibilities to grant derogations from conformity assessments by notified bodies for a limited period of time.

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.