Dr. Guido Middeler
Partner
The corona crisis has led to staffing shortages and travel restrictions that stand in the way of the necessary audits and inspections of contract manufacturers. As a result, it has become virtually impossible to implement the MDR on time in many cases. Furthermore, many practical matters and questions of interpretation surrounding the MDR remain unresolved. In many areas, the compliant and valid European guidance documents are nowhere to be found despite having been announced by the EU nearly two years ago.
The European Commission has come to realise that there is little chance of implementing the MDR on time and has announced its plans “to postpone [the] MDR application date for one year”. However, it remains rather unclear what the Commission intends to do. The Commission will submit a detailed proposal for the postponement to the European Parliament and the European Council at some point in April. The EU’s official bodies are under extreme pressure due to the current coronavirus pandemic, meaning that further delays can be expected.
For the industry, which will ultimately need to adapt to any changes in the legal situation, every day of uncertainty is one too many!
Given the continued lack of guidance, we see no other option at the present time but to advise our clients to continue making every effort to prepare for the MDR until certainty has been achieved with regard to the actual MDR application date. Without a moratorium, companies have less than two months left to prepare for the application of the MDR – even if there is no sufficient legal certainty as to how the MDR should be interpreted when it comes to matters such as the classification rules.
Policymakers need to deliver clarity as quickly as possible regarding not only the MDR application date, but also the MDR application rules. Contact us!